Quality Control Analyst

Description: Position Title: QC Analyst - Biochemistry Duration: 06 months (potential extension) Location: Lexington, MA, 02142 Job Summary/Operations Involvement: Primary Duties of this position will focus on the daily lab operations and execution of testing to support manufacturing operations /validation/or development studies. Testing may include but not limited to samples from drug substance and drug product manufacturing, stability and various protocol studies using approved test methods or test methods derived from QC technical protocols. May assist in sampling activities. This position is expected to maintain operational and GMP readiness of the QC areas as well as maintain critical reagent inventory such as antibodies and cell banks at business appropriate quantities. In addition, the individual may participate in more complex projects, operational excellence initiatives, and various quality systems with general supervision. Discretion/Latitude: Works under general supervision. Work is reviewed for soundness of judgment and overall adequacy and accuracy Impact: Exerts some influence on the overall objectives and long-range goals of the organization. Erroneous decisions or failure to achieve objectives would normally have a serious effect upon the administration of the organization. Specific Biochemistry Focus Areas: Product Testing: Area focuses on techniques such as SDS-PAGE Silver, QPCR, Potency, Kinetics assay, Enzyme Activity, pH, Osmo, A280 etc., in order to support in-process, release and stability testing. Role supports commercial and clinical testing for defined site-based and external programs, as well as method transfer and validation. Introduction of new equipment and technology to improve sustainability and compliance is expected. Additionally, the role provides support for Quality projects and implementation of operational excellence initiatives. Job Scope: Receives assignments in the form of objectives and establishes goals to meet objectives. Work is reviewed and measured based on meeting objectives and schedules. Establishes and recommends changes to policies which effect subordinate organizations. % of Time Job Function and description: 40-50%: Testing execution, participate in training analysts, trouble shooting of methods 20-30%: QC operations support which entails data review, data trending, OE/5S/LEAN initiatives, maintenance of equipment and reagents, lab house keeping, support for other QC groups. Compliance and quality systems (SOP revisions, input to quality systems records) 10-20%: Involvement in various departmental and cross-functional teams and initiatives; inspection and regulatory support Education and Experience Requirements: Typically requires a bachelor's degree and a minimum of 5+ years of related experience. (science related degree is preferred) Additional Specific Experience: Excellent communication, interpersonal and organizational skills. Ability to work well both independently and in a team environment. Ability to prioritize work and multitask. Previous experience in a GMP QC role is preferred Complete understanding and application principles, concepts, practices and standards. Full knowledge of industry practices. Position requires critical thinking. Key Skills: MS Office, LIMS, SAP, Trackwise , compliance and strong science understanding Complexity and Problem Solving Describe the decisions made by the incumbents on a regular basis. Include decisions within the Incumbent's authority to make as well as those decisions that must be referred to a higher level. Develop solutions to a variety of complex problems. May refer to established precedents and policies. Works on problems of diverse scope where analysis of data requires evaluation of identifiable factors. Demonstrates good judgement in selecting methods and techniques for obtaining solutions. Networks with senior internal and external personnel in own area of expertise. Internal and External Contacts List contacts this job advises, consults, or coordinates with on a regular basis. Describe to whom the job is accountable. Indicate each Contact category (Internal, Vendor, Customer, or Other) and provide examples. Contacts are primarily with immediate supervisor, and other personnel in the section or group. Contacts external to QC may include: Analytical Development, R&D, Quality Assurance and other Quality functions, Regulatory , Manufacturing, Facilities and Engineering Other Job Requirements: List any other job requirements, including travel, physical abilities required, etc. Limited to no travel expected. Travel between sites is required. The following physical abilities are required in order to fulfill the job duties: -Repetitive bending and reaching to setup and break-down equipment (if required by specific activity) -Ability to work around chemicals (if working around the laboratories) -Ability to wear personal protective equipment such as gloves, gowning, and respiratory protection in some cases -Ability to walk and stand for periods of time -Individual may be required to participate in environmental chamber monitoring program which would include the use of an on-call mobile phone as well as on-site support during non-business hours

Created: 2024-10-31