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Quality Assurance Compliance Specialist
1 month ago
INCOG BioPharma Services in Indianapolis, IN is seeking a highly motivated and detail-oriented Quality Assurance Compliance Specialist to implement Quality procedures and standards throughout the stages of drug product manufacturing, packaging, and release.
The Quality Assurance Compliance Specialist will work closely with the Sr. Quality Engineering Validation Manager to ensure site compliance with Regulations, Industry Standards (e.g. ISO), and organizational SOPs. They will also be key in championing and developing the organization's Quality Mindset, and culture of efficiency, attention to detail, and on-time delivery.
Key Responsibilities:- Perform primary generation and review of supplier | contractor evaluation documentation, including supplier evaluations, questionnaires, and audit reports.
- Generate and review quality agreements between suppliers and INCOG.
- Review and approve material specifications.
- Provide oversight for shipping and receiving activities.
- Perform internal audit planning and tracking of mitigations.
- Manage multiple projects in a fast-paced environment.
- Support during normal hours (8 AM – 5 PM Monday-Friday) and after business hours as needed.
- Bachelor's Degree required; degree preferred to be in a related Science (Chemistry, Biology, Biochemistry, Microbiology etc.).
- Minimum of 5 years of biopharma industry experience with increasing responsibilities in supplier quality management and/or supply chain quality.
- Excellent written and verbal communication skills.
- General computer skills evidenced by hands-on work with computerized Operations equipment (SAP); and reporting and data analysis software (Word, Excel, Visio, JMP, Minitab, etc.).
- Experience with executing or providing oversight for supplier qualification activities for FDA/EMA regulated aseptic manufacturing facilities.
- Experience with performing audits of internal and external sites/functions.
- Certified Quality Auditor, or equivalent.
- Paid time off, based on tenure
- 11 paid holidays
- 401(k) plan with company match up, vested immediately
- Choice of health & wellness plans
- FSA and HSA options
- Onsite wellness facility
- Employee engagement activities; food trucks, monthly luncheons, fundraising events, team building competitions, offsite celebrations
At INCOG BioPharma Services, we believe in equality and diversity in employment and oppose all forms of unlawful or unfair discrimination on the grounds of age, disability, sex, gender reassignment, sexual orientation, pregnancy and maternity, race, religion or belief and marriage and civil partnerships.
