QA Compliance Specialist

4 weeks ago

Fishers, United States INCOG BioPharma Full time

Working closely with the QA Compliance Manager, the Quality Assurance 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 Quality Assurance Compliance Specialist will at all times provide support with identifying and closing Operational and Quality gaps.

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

Essential Job Functions:

* Perform primary generation and review of supplier evaluation documentation, including supplier evaluations, questionnaires, and audit reports.
* Perform primary generation and review of 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.
* Support recalls and complaints activities.
* Support Annual Product Review activities.
* Generation and review of regulatory surveillance activities using Redica platform.
* Ability to manage multiple projects in a fast-paced environment.
* Provide support during normal hours (8 AM - 5 PM Monday-Friday) and after business hours as needed.

Special Job Requirements:

* 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.
* 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.

Additional info about INCOG BioPharma Services:

At INCOG BioPharma we have built a world-class CDMO for parenteral injectable drugs. Our culture and priorities are different by design: focused on building long-term value for our customers, we are committed to a service-culture mindset, technical excellence, and a collaborative and team-centered approach to doing business.

If you crave the challenge of creating systems from scratch and believe you have insights for a better way of doing business, which benefits customers by ensuring quality outcomes and accelerating their route to market, we want to hear from you. Unless otherwise specified, all positions are based out of our Fishers, IN offices. Please note, we are a smoke-free campus.

INCOG BioPharma is an Equal Opportunity Employer and prohibits discrimination and harassment of any kind. All employment decisions at INCOG BioPharma are based on business needs, job requirements and individual qualifications, without regard to race, color, religion or belief, sex (including pregnancy), age, physical disability, sexual orientation, family or parental status, or any other status protected by the laws or regulations in the locations where we operate. We will not tolerate discrimination or harassment based on any of these characteristics.

By submitting your resume and details, you are declaring that the information is correct and accurate.

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