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Quality Assurance Auditor I
Ref No.: 18-07256
Location: Cincinnati, Ohio
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
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.,
4.Accountability
Responsible for ensuring on timely releases of bulk product and cGMP compliance of the facility.