Quality Assurance Compliance Specialist

Quality Assurance Compliance Specialist

INCOG Biopharma Services in Indianapolis, IN is hiring a Quality Assurance Compliance Specialist. They are looking for a Quality Assurance Compliance Specialist who will help with implementing Quality procedures and standards and monitoring their effectiveness through execution of an Internal Audit program and vendor process evaluations and support the organization’s mission to deliver high quality products and services throughout the stages of drug product manufacturing, packaging, and release.

Working closely with the QA Compliance Manager, the QA Compliance Specialist will be instrumental in ensuring site compliance with global health authority regulations, industry standards (e.g. ISO), and organizational SOPs. They will also be key in championing and developing the organization’s Quality Mindset, Supplier Quality, Internal Audit program, support with External audits, support of Recalls and Complaints activities at INCOG, regulatory intelligence assessments, as well as annual product review. One of the key attributes for this individual would be to embrace the culture of efficiency, attention to detail, and on-time delivery. The QA Compliance Specialist will at all times provide support with identifying and closing Operational and Quality gaps.

The QA Compliance Specialist will exemplify excellent interpersonal skills and be capable of developing productive, customer-centric working relationships with colleagues, internal customers, and suppliers/partners. They will demonstrate excellent written and oral communication skills with the ability to clearly and concisely articulate complex issues to a range of target audiences, and will thrive in a team environment but will also work autonomously utilizing strong self-management and organizational skills. The QA Compliance Specialist will value process owners and subject matter experts and will possess a demonstrated ability in influencing positive outcomes without direct reporting authority.

There is a growing need globally for more CDMOs (contract development and manufacturing organization) in the pharmaceutical industry to provide comprehensive services from drug development through drug manufacturing.

At INCOG, they are more than just a CDMO. A better way to create more meaningful experiences. A better way to create a culture that everyone can thrive and succeed in. At their core, that is who they are—a dedicated team that believes they can always be better.

Join the team at INCOG, a world-class CDMO for parenteral injectable drugs, shaping a new future for yourself, INCOG's clients, and for patients.

Job Functions:

• Perform primary generation and review of supplier evaluation documentation, including supplier evaluations, questionnaires, and audit reports.
• Perform primary generation and review supplier corrective action request (SCAR) documentation and follow through to closure.
• Perform generation and review of quality agreements between suppliers and INCOG.
• Perform review of material specifications & perform internal audit planning and tracking of mitigations.
• Support External/Third party audits, recalls and complaints activities and Annual Product Review activities.
• Generation and review of regulatory surveillance activities using Redica platform.
• Ability to manage multiple projects in a fast-paced environment.

Candidate Requirements:

• Bachelor’s Degree required; preferred to be in related Science (Chemistry, Biology, Biochemistry, Microbiology etc.)
• At least 5 years of biopharma industry experience with increasing responsibilities in supplier quality management and/or supply chain quality.
• Minimum of 5 years of experience with internal audit activities
• Minimum of 2 years of biopharma industry with recall, complaints, and annual product review activities.
• 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.).

Additional Preferences:

• 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.

Why INCOG?

• 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

Don’t meet all the requirements? Don’t sweat! We’re always looking for an excuse to discuss your next opportunity. You might just surprise yourself…

Lead Candidate wholeheartedly supports Equality and Diversity in employment and opposes 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.