MANAGER QUALITY

Description POSITION SUMMARY: Manage all aspects of the Analytical Quality Control Function. Ensure compliance with all applicable regulatory requirements including FDA, EPA, DNR, BATF, and OSHA. Advise, instruct, develop, and implement policies and procedures to improve operations and maintain compliance. Mentors and trains associates on policies and procedures. Responsible for overseeing and supervision of staff and related activities. Must be versed in all routine duties of analytical QC staff (Chemistry & Raw Materials). FUNCTIONS OF THE JOB: • 1. Behavior: Exhibit Team player qualities of cooperation and coordination; professional interaction in all business contacts, all day, every day. • 2. Attendance: Present for work when scheduled is a mandatory function. • 3. Safety: Compliance with all company safety rules, procedures, and guidelines is essential. • 4. Develops, implements, and maintains quality specifications and standards for all raw materials, bulk and finished goods. • 5. Performs testing on all samples submitted for analysis, including stability, method development, and R&D support. • 6. Plans and forecasts for departmental staffing needs. Interviews job applicants, recommend qualified candidates for employment. • 7. Trains and mentors QC personnel. Assigns work tasks to lab members to ensure an efficient QC function. • 8. Provides on-going supervision and career development path to QC personnel. Conducts performance evaluations, assists employees in resolution of work related problems. Provides coaching and leadership to all personnel. • 9. Provides technical assistance and interface with other departments to improve efficiencies, work flow, and cut costs. Communicates effectively throughout the organization to ensure quality issues are addressed. • 10. Reviews customer complaints and works with other departments to address customer concerns. • 11. Develops and validates new methods and procedures. Communicates new procedures to others and ensures adequate training is conducted. • 12. Advocates GMP & GLP regulations and insures that all laboratory activities and documentation meet compliance standards. • 13. Ensure compliance with all applicable regulatory requirements including FDA, EPA, DNR, BATF, and OSHA. • 14. Actively participates in all safety programs. • 15. Coordinate and approve all OOS & incident investigations, deviations, and NCRs. • 16. Reviews and revises all laboratory policies, procedures, test methods, and job descriptions • 17. Actively participates in cross functional teams to ensure quality standards are met. • 18. Coordinates with QC staff to provide support to ensure raw materials, bulk and finished product meet OTC release timing. • 19. Ensures all instruments and laboratory equipment are performing within calibration and adequately maintained to meet GMP & GLP regulations. • 20. Understands and participates in change control process. • 21. Creates and maintains budget and lab supplies. Physical Activities: Walking, talking, hearing, climbing, balancing, reaching, grasping, standing, and stooping. Physical Demands: Occasionally lift boxes of product 5-40 lb. Frequently lift samples 1-5 lb. Visual Acuity: Clarity of vision at 20 inches or less, with the ability to distinguish colors and adjust eye to bring objects into sharper focus. Environmental/Atmospheric Conditions: Worker exposed to extreme heat and cold with temperatures sufficiently high or low to cause marked bodily discomfort. Exposed to sufficient noise to cause worker to shout in order to be heard above the ambient noise level. Worker exposed to hazards such as proximity to moving mechanical parts. Works in laboratory, production line and warehouse environments. POSITION QUALIFICATION REQUIREMENTS: Knowledge: Requires a bachelor's degree in chemistry or related scientific discipline and a thorough understanding of FDA regulations. Also requires a thorough working knowledge of laboratory methodology and procedures, chemistry, quality systems, and lab equipment. Must possess excellent written and oral communication skills. Must demonstrate a working knowledge of chemical analysis and laboratory bench work. Must possess an understanding of chemistry related math skills. Must have a working knowledge of computer usage including experience and ability to troubleshoot in SAP, spreadsheets, word processing, and database packages Experience: Minimum of 5 years QC/QA experience in a regulated industry, preferable drug, cosmetic, or food. Minimum of 3 years leadership experience. Demonstrated proficiency in a laboratory environment, time management, project development and prioritization is required. Demonstrated interpersonal skills are vital. Experience in wet chemistry operations, operation of GC, HPLC, UV-VIS, IR, KF, ICP-OES, and other laboratory instrumentation, including troubleshooting, maintenance, and repair. Must have thorough knowledge of laboratory operations with a high level of analytical problem solving skills. NON-TECHNICAL SKILLS: Requires excellent oral and written communication skills. Excellent organization skills. Ability to analyze data. Ability to handle stress and work with multiple priorities independently. Ability to interface effectively with other departments. Demonstrates excellent analytical decision-making ability. Must be able to work on multiple projects in a fast-paced environment and critically review analytical and related data to prepare technical reports in accordance with all cGMPs. Must be able to coordinate workload and work under pressure. Must be able to track projects and ensure deadlines are met. Has a professional, helpful attitude accepts constructive criticism well, and is a team player. Serves as a mentor and provides leadership to QC chemists, analysts, and technicians. Must be familiar with written and on-line reference sources including USP/NF, FCC, ACS, CTFA and other publications. Machines, Tools, Equipment and Work Aids: License(s)/Certification(s) Required: None QA CORP Micro-biology_________________________________________________ Overall responsibility for ensuring that the QC Microbiology Lab and the Validation team have sufficient processes in place to meet all necessary regulatory and customer requirements, as well as meet all customer service needs. Ensure all microbiological standards are met while providing leadership/direction to the team when needed. Proactively manage team to meet microbiology and validation goals while also meeting/exceeding customer expectations. Assign microbiological testing specifications for all raw materials and finished goods in accordance with regulatory and customer requirements. Oversee microbiology method validations for all formulas. Assist laboratory with program organization and prioritization, with focus on USP and Celsis methods. Oversee microbiological out-of-specification investigations of any non-conforming raw materials or finished goods. Monitor change controls for effects on the status of any micro-sensitive product or process. Assist in trouble-shooting any plant quality issues (all plants) specifically those related to possible microbiological contamination. Communicate with all levels of management to ensure quality issues are understood and preventive actions are taken. Champion a positive quality culture to help ensure products in the market are pure, safe & effective along with meeting customer specifications. Create and maintain the yearly budget for the Microbiology Lab. Assist contract packagers with quality issues in order to foster a positive working relationship while ensuring production and distribution of high quality products to our customers. Monitor all applicable regulatory publications for changes affecting microbiological testing. Update, maintain and strengthen all aspects of training for Microbiologists, Laboratory Technicians, Validation Engineers and designated quality personnel. Ensure all personnel keep current on data entry and generate consistent, accurate daily/monthly reports. Monitor and trend plant environmental data. Submit periodic trend reports to the VP of Quality for all corporate locations. Ensure quality team maintains compliance and adheres to commitment to safety in the workplace. Effectively address customer requests and concerns to maintain/improve customer satisfaction. Responsible for effective hiring, training, and development of team members. Champion attendance policy and ensure performance evaluations keep people informed, maintain open communication and provide timely, honest performance feedback with direction. Lead Micro Excellence Team initiatives governing all corporate sites. Supervisory Responsibilities: Education Requirements: Bachelor's degree in Microbiology or related field. Experience Requirements: A minimum of 12 years in a leadership role in an OTC (over-the-counter) drug or medical device manufacturing facility, with a majority of that experience in a Microbiology Lab environment. Extensive experience in representing multiple FDA regulated drug manufacturing and distribution sites during FDA audits. Experience in representing an OTC company during customer audits including contract customers and 3rd party auditors. A comprehensive knowledge of the FD&C Act and 21 CFR Parts 210/211 & 11 along with industry required standards for pharmaceutical and OTC drugs. Superior communication and leadership skills required. Competencies: Project management, technical writing, data analysis, knowledge of Microbiology laboratory testing and practices, and knowledge of current Good Manufacturing Practices are mandatory. Certificates, Licenses, Registrations: Travel: Work Environment: This job operates in a professional office environment. This role routinely uses standard office equipment such as computers, phones, photocopiers, filing cabinets and fax machines. Physical Demands: The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. While performing the duties of this job, the employee is regularly required to talk or hear. The employee frequently is required to stand; walk; use hands to finger, handle or feel; and reach with hands and arms. Manager Quality Microbiology _________________________________________ The Manager Quality, Microbiology will oversee the microbiology department including staff, process workflows, quality, safety, and client communication to ensure the reliability, timeliness, and accuracy of all results. The Manager of Microbiology will lead and guide all aspects of our Microbiology laboratory staff, resources, equipment, and the lab environment. This position ensures safety is closely adhered to and motivates staff to focus on preventing problems before they happen. The Microbiology Manager strengthens the overall proficiency and depth of talent in the Microbiology laboratory by establishing outstanding performance expectations and ensuring both technical and leadership skills are developed by mentoring staff. Essential Duties and Responsibilities: Overall responsibility for ensuring that the QC Microbiology Lab and the Validation team have sufficient processes in place to meet all necessary regulatory and customer requirements, as well as meet all customer service needs. Ensure all microbiological standards are met while providing leadership/direction to the team when needed. Proactively manage team to meet microbiology and validation goals while also meeting/exceeding customer expectations. Assign microbiological testing specifications for all raw materials and finished goods in accordance with regulatory and customer requirements. Oversee microbiology method validations for all formulas. Assist laboratory with program organization and prioritization, with focus on USP and Celsis methods. Oversee microbiological out-of-specification investigations of any non-conforming raw materials or finished goods. Monitor change controls for effects on the status of any micro-sensitive product or process. Assist in trouble-shooting any plant quality issues (all plants) specifically those related to possible microbiological contamination. Communicate with all levels of management to ensure quality issues are understood and preventive actions are taken. Champion a positive quality culture to help ensure products in the market are pure, safe & effective along with meeting customer specifications. Create and maintain the yearly budget for the Microbiology Lab. Assist contract packagers with quality issues in order to foster a positive working relationship while ensuring production and distribution of high quality products to our customers. Monitor all applicable regulatory publications for changes affecting microbiological testing. Update, maintain and strengthen all aspects of training for Microbiologists, Laboratory Technicians, Validation Engineers and designated quality personnel. Ensure all personnel keep current on data entry and generate consistent, accurate daily/monthly reports. Monitor and trend plant environmental data. Submit periodic trend reports to the VP of Quality for all corporate locations. Ensure quality team maintains compliance and adheres to commitment to safety in the workplace. Effectively address customer requests and concerns to maintain/improve customer satisfaction. Responsible for effective hiring, training, and development of team members. Champion attendance policy and ensure performance evaluations keep people informed, maintain open communication and provide timely, honest performance feedback with direction. Lead Micro Excellence Team initiatives governing all corporate sites. Supervisory Responsibilities: Education Requirements: Bachelor's degree in Microbiology or related field. Experience Requirements: A minimum of 12 years in a leadership role in an OTC (over-the-counter) drug or medical device manufacturing facility, with a majority of that experience in a Microbiology Lab environment. Extensive experience in representing multiple FDA regulated drug manufacturing and distribution sites during FDA audits. Experience in representing an OTC company during customer audits including contract customers and 3rd party auditors. A comprehensive knowledge of the FD&C Act and 21 CFR Parts 210/211 & 11 along with industry required standards for pharmaceutical and OTC drugs. Superior communication and leadership skills required. Competencies: Project management, technical writing, data analysis, knowledge of Microbiology laboratory testing and practices, and knowledge of current Good Manufacturing Practices are mandatory. Certificates, Licenses, Registrations: Travel: Work Environment: This job operates in a professional office environment. This role routinely uses standard office equipment such as computers, phones, photocopiers, filing cabinets and fax machines. Physical Demands: The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. While performing the duties of this job, the employee is regularly required to talk or hear. The employee frequently is required to stand; walk; use hands to finger, handle or feel; and reach with hands and arms. Summary Job description POSITION SUMMARY: Manage all aspects of the Analytical Quality Control Function. Ensure compliance with all applicable regulatory requirements including FDA, EPA, DNR, BATF, and OSHA. Advise, instruct, develop, and implement policies and procedures to improve operations and maintain compliance. Mentors and trains associates on policies and procedures. Responsible for overseeing and supervision of staff and related activities. Must be versed in all routine duties of analytical QC staff (Chemistry & Raw Materials). FUNCTIONS OF THE JOB: Behavior: Exhibit Team player qualities of cooperation and coordination; professional interaction in all business contacts, all day, every day. Attendance: Present for work when scheduled is a mandatory function. Safety: Compliance with all company safety rules, procedures, and guidelines is essential. Develops, implements, and maintains quality specifications and standards for all raw materials, bulk and finished goods. Performs testing on all samples submitted for analysis, including stability, method development, and R&D support. Plans and forecasts for departmental staffing needs. Interviews job applicants, recommend qualified candidates for employment. Trains and mentors QC personnel. Assigns work tasks to lab members to ensure an efficient QC function. Provides on-going supervision and career development path to QC personnel. Conducts performance evaluations, assists employees in resolution of work related problems. Provides coaching and leadership to all personnel. Provides technical assistance and interface with other departments to improve efficiencies, work flow, and cut costs. Communicates effectively throughout the organization to ensure quality issues are addressed. Reviews customer complaints and works with other departments to address customer concerns. Develops and validates new methods and procedures. Communicates new procedures to others and ensures adequate training is conducted. Advocates GMP & GLP regulations and insures that all laboratory activities and documentation meet compliance standards. Ensure compliance with all applicable regulatory requirements including FDA, EPA, DNR, BATF, and OSHA. Actively participates in all safety programs. Coordinate and approve all OOS & incident investigations, deviations, and NCRs. Reviews and revises all laboratory policies, procedures, test methods, and job descriptions Actively participates in cross functional teams to ensure quality standards are met. Coordinates with QC staff to provide support to ensure raw materials, bulk and finished product meet OTC release timing. Ensures all instruments and laboratory equipment are performing within calibration and adequately maintained to meet GMP & GLP regulations. Understands and participates in change control process. Creates and maintains budget and lab supplies. Physical Activities: Walking, talking, hearing, climbing, balancing, reaching, grasping, standing, and stooping. Physical Demands: Occasionally lift boxes of product 5-40 lb. Frequently lift samples 1-5 lb. Visual Acuity: Clarity of vision at 20 inches or less, with the ability to distinguish colors and adjust eye to bring objects into sharper focus. Environmental/Atmospheric Conditions: Worker exposed to extreme heat and cold with temperatures sufficiently high or low to cause marked bodily discomfort. Exposed to sufficient noise to cause worker to shout in order to be heard above the ambient noise level. Worker exposed to hazards such as proximity to moving mechanical parts. Works in laboratory, production line and warehouse environments. POSITION QUALIFICATION REQUIREMENTS: Knowledge: Requires a bachelor's degree in chemistry or related scientific discipline and a thorough understanding of FDA regulations. Also requires a thorough working knowledge of laboratory methodology and procedures, chemistry, quality systems, and lab equipment. Must possess excellent written and oral communication skills. Must demonstrate a working knowledge of chemical analysis and laboratory bench work. Must possess an understanding of chemistry related math skills. Must have a working knowledge of computer usage including experience and ability to troubleshoot in SAP, spreadsheets, word processing, and database packages Experience: Minimum of 7 years QC/QA experience in a regulated industry, preferable food, drug, or cosmetic. Minimum of 3 years leadership experience. Demonstrated proficiency in a laboratory environment, time management, project development and prioritization is required. Demonstrated interpersonal skills are vital. Experience in wet chemistry operations, operation of GC, HPLC, UV-VIS, IR, AA, and other laboratory instrumentation, including troubleshooting, maintenance, and repair. Must have thorough knowledge of laboratory operations with a high level of analytical problem solving skills. NON-TECHNICAL SKILLS: Requires excellent oral and written communication skills. Excellent organization skills. Ability to analyze data. Ability to handle stress and work with multiple priorities independently. Ability to interface effectively with other departments. Demonstrates excellent analytical decision-making ability. Must be able to work on multiple projects in a fast-paced environment and critically review analytical and related data to prepare technical reports in accordance with all cGMPs. Must be able to coordinate workload and work under pressure. Must be able to track projects and ensure deadlines are met. Has a professional, helpful attitude accepts constructive criticism well, and is a team player. Serves as a mentor and provides leadership to QC chemists, analysts, and technicians. Must be familiar with written and on-line reference sources including USP/NF, FCC, ACS, CTFA and other publications. Machines, Tools, Equipment and Work Aids: License(s)/Certification(s) Required: None Job Type: Full-time Benefits: 401(k) 401(k) matching Dental insurance Health insurance Life insurance Paid time off Vision insurance Schedule: Day shift People with a criminal record are encouraged to apply Ability to commute/relocate: St. Louis, MO 63114: Reliably commute or planning to relocate before starting work (Required) Experience: ISO 9001: 1 year (Preferred) Work Location: In person

Created: 2024-10-19