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Associate Specialist, Quality Assurance
- East Windsor, California, United States
- East Windsor, California, United States
Über
Location: East Windsor
WHERE YOU WILL WORK Without compromising our steadfast commitment to Quality, Safety and Sustainability our manufacturing and packaging facility produces in excess of 70MM units per year. This is a demonstration of our can‑do attitude, collaborative spirit, focus on innovation and continuous improvement mindset. Always People First!
JOB SUMMARY The Quality Assurance Associate Specialist is responsible for preparing and completing the CARES act report for FDA, is responsible for BOM review and approval, Bulk and Finished Good, Responsible for Releasing Finished Goods (OTC, Non‑OTC etc.) reviewing Batch records, specifications, procedures, protocols, and records for GMP compliance.
WHAT YOU WILL DO
You will prepare and complete the CARES ACT list for FDA.
You will complete BOM review and approval, set up the system specifications for Finished Goods, FG, and Bulk working closely with different departments.
You will be responsible for Releasing Finished Goods (OTC, Non‑OTC, etc.).
You will prepare master production records for all OTC products.
You will review raw material, packaging material, in‑process material and finished product specifications for GMP compliance – Reconciliation of OTC Batch Records.
You will perform review of Production batch records and control records for OTC products and initiate investigation for any unexplained discrepancy found during review. Prepare Certificate of Manufacturing and Compliance and release OTC products for shipment.
You will aid in investigations as required.
You will file and maintain batch production and control records for OTC product.
You will conduct/review Annual Product Review of OTC products. Record the observations that needs follow up with AIC team.
You will provide GMP Training to other departments as needed.
You will research and prepare data as needed for monthly quality metrics reporting.
You will assist in any projects/tasks assigned by the Manager.
WHO YOU ARE
You have a bachelor’s degree (B. A.) from a four‑year college or university, preferably in Engineering or Science.
You have two years’ knowledge of pharmaceutical GMP documentation requirements and quality assurance experience in a regulated industry.
You have a good understanding of 21CFR (Part210-211), ICH guidelines.
You have experience with SAP systems.
You are an expert in Excel and PowerPoint presentation.
You have good verbal and written communication skills.
PHYSICAL REQUIREMENTS The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job, if applicable. Reasonable accommodation may be made to enable individuals with disabilities to perform the essential functions.
Employees must be able to wear personal protective equipment (PPE) as required by the area of work or tasks being performed. Required PPE may include, but is not limited to, eye protection, hearing protection, safety shoes, gloves, or additional protective clothing.
Standing : Under 1/3
Walking : Under 1/3 |
Over 2/3
Use hands to finger, handle or feel : Not Applicable
Climb or balance : Under 1/3
Reach with hands and arms : Under 1/3
Stoop, Kneel, Crouch, or Crawl : Not Applicable
Up to 10 pounds : Under 1/3
Up to 25 pounds : Under 1/3
Up to 50 pounds : Not Applicable
Up to 100 pounds : Not Applicable
Salary (Min-Max): 65,992-90,739
Job Segment: QA, Facilities, Quality, Operations, Research
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Sprachkenntnisse
- English
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