Back to searchQA Associate 1
Manpower Engineering
Posted 8 hours ago, valid for 6 months
Winchester, KY 40391, US
$48,000 - $57,600 per annum
Part Time
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Sonic Summary
- The QA Associate position in Winchester, KY requires oversight of manufacturing operations for solid oral dosage products, ensuring compliance with cGMP and CFR guidelines.
- Candidates should have a minimum of a High School Diploma with at least 4 years of relevant experience in a regulated GMP manufacturing environment, or a Bachelor's Degree with 2 years of experience.
- The role involves real-time monitoring of manufacturing activities, reviewing SOPs, and conducting environmental monitoring through microbial swabbing.
- The salary for this position is not explicitly stated but is typically competitive within the industry for such roles.
- Additional qualifications such as Lean Six Sigma or ASQ certification are preferred for applicants.
Location: Winchester KY (Onsite)
SHIFT - MON-FRI 10PM - 6:30AM.
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 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:
• 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 Client’s 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: (Minimum required to perform job)
• Preferred - Bachelors Degree in related science or technical field in combination with 2 years prior relevant work experience.
• Minimum of High School Diploma in combination with 4+ years of relevant work experience in a regulated GMP manufacturing environment.
• Additional qualifications desired are Lean Six Sigma, ASQ certification or other professional certifications.
