Quality Assurance Associate
Winchester, KY 40391 US
The QA Associate is responsible for the Quality support functions associated with the manufacturing of solid oral dosage products for a given business unit. The essential responsibilities associated with this position are oversight of the manufacturing operations (as dictated by cGMP, CFR, and SOP) through document review/approval, real time monitoring/approval of manufacturing activities and testing/approval of in-process and finished product samples.
II. Specific Tasks, Duties and Responsibilities:
RESPONSIBILITIES INCLUDE, BUT ARE NOT LIMITED TO:
- Recommend SOP and batch record changes as needed
- Review proposed SOP revisions and provide feedback to management
- Real-time audit of batch records in the production suites for completeness, documentation, calculation errors and conformance to critical process parameters
- Perform room and equipment clearances per procedure following cleaning conducted by production.
- Perform microbial swabbing of equipment and room surfaces for environmental monitoring.
- Maintain a full understanding of all SOPs and policies along with all cGMP and CFR guidance that are applicable to the manufacturing of solid oral dosage pharmaceutical products.
- Perform routine testing of in-process and finished product samples including particle size, bulk density, moisture analysis, appearance, and AQL testing real-time.
- Monitor production manufacturing areas for compliance to SOP/cGMP/batch record and safety requirements in order to identify and resolve routine errors and prevent possible deviations that affect production real-time.
- Works cross functionally to assess impact for potential deviations and assist in identifying if an investigation is required.
- Initiate deviation problem reports in Trackwise for issues discovered by QA, providing sufficient detail of the incident so that a full investigation by the responsible department can be conducted.
- Manage quality status of WIP and finished good materials on physical inventory and in inventory system (JD Edwards)
- Other assignments as needed within the scope of QA Associate training curriculum.
- Assist in investigations for deviations by supporting data gathering and root cause analysis
- Enforcement of GMP Compliance.
- Promotes team work and good communication.
- Provide training and coaching to manufacturing staff as needed
- Support site process improvements (training, efficiency projects, implementation of CAPAs)
- Supports customer complaint investigation by performing inspection of retains and complaint samples
III. Essential Skills and Experience:
Education or Experience:
- Bachelors Degree in related science or technical field preferred with 2 years prior work experience
- Minimum of High School Diploma with 4+ years of relevant experience in a regulated GMP manufacturing environment.
- Additional qualifications desired are Lean Six Sigma, ASQ certification or other professional certification
- Familiarity with basic laboratory instrumentation
- Safe work habits
- Basic math and computer skills
- Good communication skills
- Ability to follow written and verbal instructions
- Able to work with limited supervision for routine tasks
- Excellent documentation and handwriting skills
- Proficient reading and comprehension skills
- Sound decision-making, technical and problem-solving skills
- Good time management skills
- Expert technical writing and problem-solving skills
- Good Laboratory Practices
- Experienced with continuous improvement techniques
- Demonstrates initiative
Although this hasn't been an issue at The Planet Group, the staffing industry has seen an increase in people falsely representing themselves as recruiters to gather personal information from job seekers. For your safety, do not provide sensitive data to anyone you have not spoken with thoroughly and never provide banking information during the application process. Candidate safety is a top priority at The Planet Group.