Manufacturing - Quality Assurance Associate
About The Position
This is a temporary-to-hire position with a duration of 6 months, located onsite. The shift is Monday-Friday from 2 PM to 10:30 PM, with mandatory overtime. The role involves ensuring compliance with cGMP and CFR guidelines in the manufacturing of solid oral dosage pharmaceutical products. Key responsibilities include reviewing and recommending SOP changes, auditing batch records, performing environmental monitoring, and conducting in-process and finished product testing. The associate will also monitor production areas for GMP compliance, initiate deviation reports, manage material quality status, and assist in investigations and process improvements.
Requirements
- Bachelors degree; OR Associates with 1 year of related work experience; OR High School Diploma/GED with 2 years of related work experience
- 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
Nice To Haves
- Experience with JD Edwards inventory system
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
Benefits
- TEMP TO HIRE
Stand Out From the Crowd
Upload your resume and get instant feedback on how well it matches this job.
What This Job Offers
Job Type
Full-time
Career Level
Entry Level
