Quality Control & Quality Affairs (QC/QA) Associate II
About The Position
Join Our Team as a Quality Control & Quality Affairs (QC/QA) Associate II. This role involves overseeing production line clearances, ensuring timely batch release, and managing document change requests. The associate will also be responsible for part number assignment accuracy, supporting deviation and CAPA investigations, and maintaining the retention sample program. Additionally, the role includes conducting label reviews, supporting product and raw material testing, and managing equipment calibration and environmental monitoring. In Quality Assurance, responsibilities include managing product and customer complaints, administering the supplier qualification program, and supporting other QA tasks as assigned.
Requirements
- Applied Science or an Associate's degree in a comparable field
- 2 years of experience in a comparable field
- 2 years of cGMP experience
- MS Office Suite-intermediate skill level
- Must be able to walk, bend, stoop, and operate instrumentation requiring hand dexterity.
Nice To Haves
- 3+ years of cGMP experience
- Bachelor's degree in a comparable field
- Experience with finished product testing and sampling
- Experience with 21 CFR Part 111 Dietary Supplements
- Technical writing experience (SOP, Regulatory submissions, technical reports)
Responsibilities
- Oversee production line clearances for both manufacturing and bottling operations.
- Ensure timely batch release, providing back-up support as needed.
- Review and approve document change requests.
- Maintain accuracy in part number assignment.
- Support the initiation, investigation, and resolution of complex deviations and CAPA reports.
- Design, support, and maintain the retention sample program, ensuring on-time finished product testing.
- Conduct label review and inspection to ensure compliance and accuracy.
- Support final product and raw material testing and release processes.
- Manage and monitor equipment calibration activities.
- Perform environmental monitoring, including monthly air, plate, and water sampling in manufacturing, bottling, and RO water systems.
- Manage product and customer complaints, including initiating and leading investigations through resolution.
- Maintain and administer the supplier qualification program.
- Support additional QA responsibilities as assigned.
Benefits
- Medical, Dental, and Vision Insurance Plans
- Health Savings Account (HSA) & Flexible Spending Account (FSA) options
- Health Savings Account Match
- Company Paid Life, Short-Term & Long-Term Disability Insurance
- 401(k) with up to 4% Company Match
- Four (4) weeks Paid Time Off
- Gym Membership Reimbursement
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What This Job Offers
Job Type
Full-time
Career Level
Mid Level
Education Level
Associate degree
