Field Specialist QA Operations

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Share job Field Specialist QA Operations - Contract - Devens, MA - $50.00 - $60.00/hr. The final salary or hourly wage, as applicable, paid to each candidate/applicant for this position is ultimately dependent on a variety of factors, including, but not limited to, the candidate's/applicant's qualifications, skills, and level of experience as well as the geographical location of the position. Applicants must be legally authorized to work in the United States. Sponsorship not available. Our client is seeking a Field Specialist QA Operations in Devens, MA. Role Description The Contractor Field QA Specialist is responsible for quality activities for the Single Use Facility in accordance with client policies, standards, procedures, and Global cGMP. Functional responsibilities include ensuring manufacturing compliance with applicable procedures and batch records, providing real time review of manufacturing batch record documentation and logbooks, and working with operations to resolve manufacturing issues. The Contractor Field QA Specialist role is stationed in Devens, MA and reports to the Senior Manager of QA Operations for the Devens SUF. JOB RESPONSIBILITIES • Perform QA on the floor activities. • Ensure manufacturing compliance with applicable procedures and batch records. • Perform real time review of manufacturing batch records. • Review manufacturing shop floor documentation. Skills & Requirements EDUCATION REQUIREMENTS • High School Degree required • Relevant college or university degree preferred. • Minimum 4 years relevant work experience, with experience in a Quality Assurance role. QUALIFICATIONS REQUIRED • Equivalent combination of education and experience acceptable. • Must be action-oriented and skilled in decision-making, building relationships, problem solving, conflict management, planning and organizing, resource allocation, coaching others, and analytical thinking. • Understands continuous improvement and improves efficiency and productivity within the group or project. • Builds relationships internally within and with cross functional teams. • Must have sound knowledge and experience in FDA regulated cGMP warehousing, Quality, and compliance environments. Prefer to also have knowledge of GMP Manufacturing operations and processes. • Directs quality initiatives that accomplish continuous improvement and enhance site quality system efficiencies. • Routinely recognizes and resolves Quality issues; Informs management of proposed solutions. Seeks management guidance on complex issues. • Able to recognize conflict and notify management with proposed recommendations for resolution. • Must possess an independent mindset. Work is self-directed. • Requires moderate direction to complete more complex tasks; completes routine tasks with little or no supervision. • Confident in making decisions for non-routine issues. • Develops and revises procedures. • Intermediate to advanced ability to interpret results and situations and articulate recommendations for resolution. • Able to prepare written communications and communicate problems to management with clarity and accuracy. • Able to effectively multi-task. • Knowledge of US and global cGMP requirements. Must have strong authorship and ability to critically review investigations, interpret results and generate technical conclusions consistent with Quality risk management principles. • Must be skilled in planning and organizing, decision-making, and building relationships. • Knowledge of quality processes, including material disposition, change control, product complaints, deviations, investigations, and CAPA management. • Able to effectively multi-task. • Must have strong authorship and ability to critically review investigations, interpret results and generate technical conclusions consistent with Quality Risk Management principles. • Must be skilled in planning and organizing, decision-making, and building relationships. • Knowledge of quality processes, change control, product complaints, deviations, investigations, and CAPA management. Additional Information: No requirements for lifting or driving equipment No exposure to hazardous materials Benefits/Other Compensation This position is a contract/temporary role where Hays offers you the opportunity to enroll in full medical benefits, dental benefits, vision benefits, 401K and Life Insurance ($20,000 benefit). Why Hays? You will be working with a professional recruiter who has intimate knowledge of the industry and market trends. Your Hays recruiter will lead you through a thorough screening process in order to understand your skills, experience, needs, and drivers. You will also get support on resume writing, interview tips, and career planning, so when there's a position you really want, you're fully prepared to get it. Nervous about an upcoming interview? Unsure how to write a new resume? Visit the Hays Career Advice section to learn top tips to help you stand out from the crowd when job hunting. Hays is committed to building a thriving culture of diversity that embraces people with different backgrounds, perspectives, and experiences. We believe that the more inclusive we are, the better we serve our candidates, clients, and employees. We are an equal employment opportunity employer, and we comply with all applicable laws prohibiting discrimination based on race, color, creed, sex (including pregnancy, sexual orientation, or gender identity), age, national origin or ancestry, physical or mental disability, veteran status, marital status, genetic information, HIV-positive status, as well as any other characteristic protected by federal, state, or local law. One of Hays' guiding principles is 'do the right thing'. We also believe that actions speak louder than words. In that regard, we train our staff on ensuring inclusivity throughout the entire recruitment process and counsel our clients on these principles. If you have any questions about Hays or any of our processes, please contact us. In accordance with applicable federal, state, and local law protecting qualified individuals with known disabilities, Hays will attempt to reasonably accommodate those individuals unless doing so would create an undue hardship on the company. Any qualified applicant or consultant with a disability who requires an accommodation in order to perform the essential functions of the job should call or text 813.336.5570. Drug testing may be required; please contact a recruiter for more information. #LI-DNI

Created: 2024-10-29