Overview
Manufacturing – Quality Assurance Associate Jobs in Winchester, USA at Medvacon Life Sciences, LLC
Job Details
TEMP TO HIRE – DURATION – 6 MONTHS – ONSITE POSITION – SHIFT – MON-FRI 2PM – 10:30PM + MANDATORY OVERTIME.
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 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 teamwork and good communication
- Provide training and coaching to manufacturing staff as needed
- Support site process improvements (training, efficiency projects, implementation of CAPAs)
- Completes investigations of customer complaints
Qualifications
- Quality Assurance Associate
- Bachelors degree; OR
- Associates with 1 year of related work experience; OR
- High School Diploma/GED with 2 years of related work experience
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Title: Manufacturing – Quality Assurance Associate
Company: Medvacon Life Sciences, LLC
Location: Winchester, USA
Category:
