Acro Service Corp
Acro Service Corp is hiring: Manufacturing Technician in Winchester
Acro Service Corp, Winchester, KY, US, 40392
Job Title: QA Associate 1
Location: 1100 Enterprise Drive, Winchester, KY 40391
Duration: 6 months temp to hire
Pay Rate: $26.40/hr. on W2 (without benefits)
SHIFT: MON-FRI 10PM - 6:30AM
Description: 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.
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 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
Work 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
Promote teamwork and good communication
Provide training and coaching to manufacturing staff as needed
Support site process improvements (training, efficiency projects, implementation of CAPAs)
Support customer complaint investigation by performing inspection of retains and complaint samples
Essential Skills and Experience: Preferred - Bachelor’s 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
Seniority level: Entry level
Employment type: Contract
Job function: Manufacturing, Purchasing, and Product Management
Industries: Manufacturing, Pharmaceutical Manufacturing, and Retail Pharmacies
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