Quality Assurance Manager with Expert Microbial Analytical Oversight
3 weeks ago
Job Description:
We are seeking a Quality Assurance Manager to oversee our microbial analytical activities. This role will involve reviewing and approving documents related to raw materials, packing materials, in-process products, finished products, and stability studies.
The ideal candidate will have at least 10-14 years of experience in microbial analytical activities and be knowledgeable about QMS procedures, software compliance, and audit trail reviews.
In this role, you will also be responsible for investigating and reviewing laboratory out-of-specification (OOS), out-of-trend (OOT), and incident reports, as well as providing support in assessing change control requests.
You will work closely with the cross-functional team (CFT) to ensure closure of action points within the agreed timeframe and provide deliverables for Computer System Validation (CSV).
This is an excellent opportunity to join Par Formulations and contribute to the success of our company.
Responsibilities:
- Review and approval of microbial analytical documents
- Investigation and review of laboratory OOS, OOT, and incident reports
- Assessment of change control requests
- Delivery of CSV deliverables
Requirements:
- At least 10-14 years of experience in microbial analytical activities
- Knowledge of QMS procedures and software compliance
- Audit trail review expertise
What We Offer:
We offer a competitive salary range of $120,000 - $180,000 per year, depending on experience, as well as a comprehensive benefits package, including medical, dental, and vision insurance, 401(k) matching, and paid time off.
About Us:
Par Formulations is committed to diversity, equity, and inclusion and welcomes applicants from diverse backgrounds. We strive to create a workplace culture that values and respects each employee's unique perspective and contributions.
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