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Quality Assurance Auditor I
Ref No.: 18-05241
Location: Cincinnati, Ohio
Start Date / End Date: 05/07/2018 to 04/30/2019
Job Title: Quality Assurance Auditor I
Duration: 1 year
Location: Cincinnati, OH

Job Description:
  • WEEKDAY NIGHT SHIFT - Monday through Thursday 8:00 pm- 6:30 am
  • Candidate must be able to make decisions during this shift when needed.
  • Responsible for reviewing documentation for batches that are manufactured and packaged. Assure compliance with cGMP before being released for further processing, packaging or commercial market.
Essential Duties & Responsibilities:
1. Review completed manufacturing and packaging documents, as well as laboratory test specification sheets.
2. Ensure all pertinent information is compiled, reviewed and approved prior to any product disposition
3. Identifies improvements/new procedures/ compliance gaps based on applicable regulations.
4. Assign QA status (Release/Reject/Quarantine/Impound) to work-in-process and finished product.
5. Investigates and troubleshoots all routine problems which occur during work assignments.
6. Coordinate all necessary paperwork for batch release.

Position Requirements:
  • Education Required: 4-year Bachelor's Degree required
  • Education Preferred: 4-year Bachelor's Degree preferable in the sciences
  • Experience Required: 1 to 3 years experience within a pharmaceutical or related manufacturing facility
  • Experience Preferred: N/A
  • Company-Related Knowledge: Thorough knowledge of cGMP's.
  • Specialized or Technical Knowledge Licenses, Certifications needed: Ability to perform basic statistics and understanding of AQL sampling plans
  • Functional Knowledge: Must work with computers and with computer systems on a continual basis
  • Knowledge of word processing, spreadsheet, and database programs
Job-specific Competencies:
1.Communication Skills
Ability to read, understand and follow written instructions such as SOPs, batch records, cGMPs, etc.
Must express oneself clearly and concisely when conveying information, summarizing facts, asking questions, etc.
Must effectively work with different departments and communicate with all levels of management.
2.Time Management
Ability to coordinate several activities at once while ensuring on time releases of finished products.
3.Problem Solving / Decision Making
Must work with planning, manufacturing, packaging, and distribution to ensure proper priorities are set and necessary activities are planned to meet these goals.,
Responsible for ensuring on timely releases of bulk product and cGMP compliance of the facility.

Shiva Prasad | Senior Recruiter
Sunrise Systems Inc.
Desk: (732) 272 0346
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