Quality Assurance Technician II
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The Opportunity
Description
- Execute batch record review and document deficiencies in a computerized system
- Identify exceptions and report exceptions to production
- Resolve documentation discrepancies and issues with manufacturing operations personnel in a timely manner to allow for material release
- Perform batch record accountability and Iron Mountain box reconciliation
- Execute line clearances and assist in inspection of returned goods
Our Client
Our client is an award-winning clinical development company. Improving lives globally with 20+ years experience in clinical research and strategic resourcing. Elevating results with proven strategies, comprehensive solutions, and customized delivery models.
Serving pharmaceutical, biopharmaceutical, biotechnology, and medical device organizations.
Strong relationships provide you connections and access to great opportunities. Industry expertise sets you up for success with helpful insights, career coaching, and professional training. Grow and learn while you put your skills to work.
Experience Required for Your Success
- HS Diploma is required; Associates or Bachelors degree is preferred
- Minimum of 1-3 years of document review experience in a cGMP environment preferred
- Proven knowledge of FDA and cGMP regulations preferred
- Proficiency in MS Word and Excel
- LIMS and BPCS experience preferred
- Ability to communicate at a high level of written and oral skills
- Ability to read and comprehend complex calculations and formulas
- Ability to focus and review batch records for an extended period of time
- Knowledge of GMPs for APIs
- Ability to quickly identify, communicate and/or resolve issues
- Ability to read and understand complex batch records
- Ability to keep batch records organized and easily retrievable at all times
- Excellent verbal and written communication skills
- Ability to understand and apply good documentation practices
- Ability to build relationships with partners
What Do You Think?
Does your experience reflect what it takes to be successful in this role? Do the work and challenges get you excited about what's possible?
