Quality Assurance Manager
Grand Rapids, MI
SRG offers flexible staffing solutions with a national presence. We provide contract, contract-to-hire, direct hire and executive search services. SRG utilizes an innovative approach to identify and qualify talent that is unique to the Staffing industry, featuring a cutting-edge platform that allows us to rapidly and precisely match professionals to client requirements. We have a proprietary database of over one million candidates and maintain continuous contact with our qualified talent.
Title: Quality Assurance Manager
Location: Grand Rapids, Michigan
Hours: 1st Shift
Employment Type: Permanent
Provides direction and leadership of the clients Quality Systems with oversight of Aseptic Manufacturing (formulation and filling) operations for two facilities. This position works closely with all levels of the Operations (Manufacturing and Finishing), Technical Services, Validation, QC (Microbiology and Analytical Chemistry), Business and Finance teams.
- Provide leadership to Quality Specialists of various levels. Responsibilities include managing, motivating, coaching and mentoring.
- Ensure Quality support and oversight of Aseptic Manufacturing operations across three shifts, including occasional weekend support, for two manufacturing facilities.
- Oversight and management of the batch record review / in-process release processes
- Review, assessment and approval of non-conformance reports, including deviations, laboratory / OOS investigations and environmental investigations.
- Client support / interaction related to these processes.
- Interface with auditors, including client representatives and regulatory agencies.
- Perform Quality Assurance review and approval of cGMP documentation in support of continuous improvements, including (o Procedures o Test Methods o Master Batch Records o Risk Assessment Reports)
- Support Agency, customer and vendor audits as needed.
- Candidate must have a minimum Bachelor s degree in scientific discipline
- At least 4 years of prior management / leadership experience required in a GMP manufacturing environment.
- Prior experience interacting with regulatory authorities is preferred
- Must have aseptic and/or sterile fill or finish experience
- A thorough understanding of cGMP, FDA guidelines and multinational regulatory standards is required; experience and expertise in aseptic manufacturing of regulated products is preferred.
- Ability to interpret and relate Quality standards for implementation and review.
- Knowledge of Quality principles and procedures in a pharma, biopharma, and/or biotech manufacturing environment.
- Ability to portray an appropriate level of integrity and professionalism at all times.
- Ability to communicate effectively with management, staff, regulators and client representatives, in both written and verbal forms.
- Ability to complete tasks accurately and according to established timelines.
- Demonstrated management ability with a proven track record of leading teams to meet objectives.
- Ability to make sound decisions about scheduling, allocation of resources and managing priorities.
- Proficiency in both written and verbal communication and presentations.
- Energetic, self-motivated, organized individual who is accustomed to working in a deadline-focused, high-pressure entrepreneurial environment.
- Results oriented and efficient.
- Creative and open-minded who fosters an environment in which sharing of ideas is encouraged.
- Ability to work closely with a diverse customer base (internally and externally).
- Ability to work well in a cross-functional team environment.
- Must have proficient computer skills in Microsoft Word, Excel and Outlook.
Search words: Investigations, cGMP, QA, Quality Assurance, pharmaceuticals, manufacturing, compliance, samples, finished products, batch records, documents, aseptic, sterile