Quality Assurance Officer (Hybrid) - Parsippany, NJ
Bring your passion. Build the future.
We're #hiring for:
Quality Assurance Officer (Hybrid)
Location: Parsippany, NJ
What you’ll do:
As a Quality Assurance Officer, you will ensure all contract manufacturing documentation is reviewed for adequacy and maintained on within DSM documentation files. Additionally, you will be responsible for provide support with product releases and metrics trending. This role will l also include supporting DSM personnel as necessary on GMP activities, ensuring that site procedures are enforced and provide guidance to not only local management of best practices, but also continuously ensuring that all individuals including self-adheres to all requirements pertaining to ISO9001.
We bring:
Working for DSM means the opportunity to really contribute to improve people’s lives and solving the challenges of today’s world. Challenging jobs, career opportunities and an inspiring environment allow you to enhance your personal development. DSM recognizes that the on-going success of the company depends on the continued development and engagement of our employees and pursues a fair and competitive remuneration policy, recognizing individual and team competencies and performance.
Key responsibilities:
- Review Inspection forms / Release of products in LIMS
- Ensure Supplier CoA Verification completed as outlined by SOP.
- Complete a biennial review with the CMO to review and verify all current templates are the latest versions and all documentations are up to date and accurate. In addition, request updated Master Manufacturing Records and Master Packaging Records and corresponding executed batch and packaging records for each product.
- Ensures that product release or rejection decisions on batch level in regard of quality attributes are in full compliance with applicable GMP rules, regulatory and legal requirements, and customer agreements.
- Perform/support/review Deviation/Investigation Reports and Root Cause Analysis for non-conforming product or process deviations as necessary.
- Track applicable testing or product registration requirements to assure and maintain completion as necessary (Kosher/Halal, GMO, Allergen, Annual testing, Full Lot testing, and Product Quality Review activities.
- Preparation of Customer Letters of Acceptance, Quarantine Letters and Signature Release Letters as warranted
You bring:
- Bachelor’s degree in a relevant scientific or engineering discipline is required (chemistry, biochemistry, food technology).
- Knowledge of 21 CFR part 117/111 and previous experience or exposure to other quality standards, such as ICH Q7, FSSC 22000, ISO 9001, ISO 17025 and NNHPD GMPs is preferable.
- Good administrative skills, good knowledge of office software (Word, Excel, Note, PowerPoint).
- Some familiarity with using DSM quality systems (e.g., Trackwise or EDM) is a benefit.
- Some familiarity with using ERP systems (e.g., SAP) is a benefit.
DSM NA is an Equal Opportunity and Affirmative Action Employer. DSM is committed to ensuring equal employment opportunities for all job applicants and employees. Employment decisions are based upon job-related reasons regardless of an applicant's race, color, religion, sex, sexual orientation, gender identity, age, national origin, disability, marital status, genetic information, protected veteran status, or any other status protected by law.