Job Description
Department: Quality Assurance
Location: Brighton, Michigan
Job Title: Quality Assurance Associate
Reports to: Quality Assurance Manager
General DescriptionThe Quality Assurance Associate is a member of the Quality Assurance department responsible for overseeing and assisting in all aspects of Quality Systems Management. The QA associate role will function in two capacities:
1) Document generation, review, approval, and/or training in support of CGMP quality systems and operations,
2) QA on the floor during all manufacturing operations.
DUTIES AND RESPONSIBILITIESEssential Duties and Responsibilities:
1. Develop, review, approve, and/or maintain documents that support both Quality Assurance and Operations. This may include Batch Records, Protocols and Reports (Engineering, Validation, Qualification, Stability, etc.), Risk Assessments, Process Flow Diagrams, Standard Operating Procedures (SOP's), Investigations, and any other technical documents as required,
2. Lead/represent QA on project teams in support of new product and manufacturing activities,
3. Review and approve incoming materials including but not limited to active pharmaceutical materials, excipients, components, and packaging materials,
4. Perform Quality oversight during manufacturing operations, including identifying and implementing process improvements through change control, investigations of non-conforming material, equipment, processes, etc., and review of the manufacturing documentation (batch records, logbooks, analytical testing data, protocol(s), etc.),
5. Perform review and approval of executed documents,
6. Assist in the identification, action, and resolution of changes and issues during manufacturing activities,
7. Develop and implement SOPs specifically related to CGMP quality systems, operations, and the facility, including training and training file maintenance,
8. Assist in management of quality systems on a company-wide basis, including document control, vendor quality, training, CAPA, change management, auditing, validation/qualification programs, and non-conformance investigations,
9. Other duties as defined by Biovire.
Behavioral Expectations:
1. Strong work ethic and ability to accomplish tasks without supervision,
2. Demonstrate leadership both by words and leading by example to foster Biovire One Team culture,
3. Strong organizational skills and the ability to focus on multiple projects in a fast-paced work environment,
4. Excellent interpersonal skills with the ability to communicate effectively,
5. Basic computer skills (proficient in Microsoft Office applications),
6. Excellent communication skills, both written and verbal,
7. Possess honesty and integrity with a commitment to the highest legal and ethical standards,
8. Treats every person with courtesy and respect,
9. Knowledge of CGMP and regulatory principles,
10. Commitment to quality in the manufacturing process,
11. Ability to independently analyze and resolve complex issues,
12. Strong sense of initiative, accountability, and responsibility
WORK EXPERIENCE AND EDUCATION REQUIREMENTS· BS in scientific discipline
· 3+ years experience in the biotech/pharmaceutical industry preferred
· Demonstrated knowledge and understanding of CGMP and CGMP Quality Systems
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