QA Associate for IQC - 2nd shift
Description
Quality Assurance Associate for Incoming Quality Control (QA Associate for IQC) (2nd Shift) Summary
This role offers a valuable chance to collaborate with various functional groups, such as IQC, Supply Chain, and the warehouse—all within Quality Assurance. Working closely with the QA Technical Services Manager and QATS Supervisor, the candidate will be responsible for overseeing and supporting the release of materials, including raw materials, components, and consumables. The ideal candidate will contribute to the release of excipients and raw materials from IQC while identifying operational and quality gaps throughout the stages of Drug Product Manufacturing, Packaging, and Release. Throughout these tasks, they must maintain a strong Quality mindset in accordance with GDP and cGMP guidelines.
Essential Job Functions:
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Maintain a Quality Assurance presence by verifying incoming pharmaceutical shipments and contents against purchase orders, material specifications, and receiving requirements in accordance with INCOG SOPs.
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Collaborate with IQC and Supply Chain to perform both provisional and full release of materials.
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Dispose of Filled Inspected Product (FIP) rejects following batch disposition.
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Release materials in the warehouse noting any discrepancies, or expired items and report any issues to the Warehouse Manager.
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Utilize various paper and automated systems (Veeva, SCADA, BMS, CMMS, LIMS, etc.) to ensure data integrity for site policies, procedures, and material release.
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Exemplify and take proactive approaches in terms of safety expectations, practice positive intervention, and enforce best practices that align to SOPs, compliance requirements, quality guidelines, and site goals.
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Ability to manage multiple projects in a fast-paced environment.
Special Job Requirements:
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This position will support primarily second shift (3:00pm-11:30pm) with occasional weekend support, dependent on operations’ needs.
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Bachelor’s Degree prferred or 1-3 years of relevant experience; degree preferred to be Biology or Chemistry.
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Understanding of Good Documentation Practices (GDPs) and its criticality.
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Exemplifies excellent interpersonal skills and can develop productive working relationships with colleagues, customers, suppliers, and partners. Demonstrated ability to influence positive outcomes without direct reporting authority.
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Commits to a culture of quality with skills including attention to detail, on time delivery, and efficiency.
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Ability to lift 50 lbs.
Additional Preferences:
- Capable of organizing and managing the schedule to meet shifting priorities and deadlines, all while maintaining quality.
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.