Pharmaceutical Quality Assurance Associate
Company: Biovire
Location: Brighton
Posted on: February 22, 2026
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Job Description:
Job Description Job Description Department: Quality Assurance
Location: Brighton, Michigan Job Title: Quality Assurance Associate
Reports to: Quality Assurance Manager General Description The
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
RESPONSIBILITIES Essential 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
Keywords: Biovire, Detroit , Pharmaceutical Quality Assurance Associate, Science, Research & Development , Brighton, Michigan
