QA Compliance Specialist
Description
Working closely with the Sr. Quality Engineering Validation Manager, the Quality Assurance Compliance Specialist will be instrumental in ensuring 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. 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 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 | contractor evaluation documentation, including supplier evaluations, questionnaires, and audit reports.
- Perform generation and review of quality agreements between suppliers and INCOG.
- Perform review and approval of material specifications.
- Provide oversight for shipping and receiving activities.
- Perform internal audit planning and tracking of mitigations.
- Ability to manage multiple projects in a fast-paced environment.
- Provide support during normal (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.
- 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.