QA Associate 1

Alltech Consulting Services; Winchester; On-site; GBP 30,000 - 40,000; Full time

Job summary

A leading consulting firm is seeking a QA Associate responsible for ensuring quality support in the manufacturing of solid oral dosage products. The role includes oversight of manufacturing operations, real-time monitoring, testing of in-process products, and maintaining compliance with GMP standards. Ideal candidates have a Bachelor's Degree or a High School Diploma with substantial relevant experience in a regulated environment.

Qualifications

• 2 years of relevant experience in a regulated GMP environment preferred.
• 4+ years of relevant experience in a regulated GMP environment minimum.
• Lean Six Sigma or ASQ certification is desirable.

Responsibilities

• Oversight of manufacturing operations through document review.
• Real-time audit of batch records in production.
• Perform routine testing of in-process and finished products.
• Monitor manufacturing areas for compliance and safety.

Skills

Quality Control

Documentation Accuracy

Real-time Monitoring

Analytical Testing

Teamwork

Education

Bachelor’s Degree in a related science or technical field

High School Diploma

Job description

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Position Overview

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 of this position include oversight of manufacturing operations (as dictated by cGMP, CFR, and Company SOPs) 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:

1. Recommend SOP and batch record changes as needed.
2. Review proposed SOP revisions and provide feedback to management.
3. Real-time audit of batch records in production for completeness, documentation accuracy, calculation errors, and conformance to critical process parameters.
4. Perform room and equipment clearances following cleaning procedures.
5. Conduct microbial swabbing of equipment and room surfaces for environmental monitoring.
6. Maintain full understanding of all SOPs, policies, cGMP, and CFR guidance applicable to manufacturing.
7. Perform routine testing of in-process and finished products, including particle size, bulk density, moisture analysis, appearance, and AQL testing in real-time.
8. Monitor manufacturing areas for SOP/cGMP compliance and safety, identifying and resolving errors to prevent deviations.
9. Work cross-functionally to assess impact of potential deviations and determine if investigations are needed.
10. Initiate deviation reports in Trackwise, providing detailed incident information for investigation.
11. Manage quality status of WIP and finished goods in inventory systems.
12. Assist in investigations of deviations, supporting data gathering and root cause analysis.
13. Enforce GMP compliance.
14. Promote teamwork and effective communication.
15. Provide training and coaching to manufacturing staff as needed.
16. Support process improvements, training, efficiency projects, and CAPA implementation.
17. Support customer complaint investigations by inspecting retains and complaint samples.

Essential Skills and Experience:

Education or Experience (Minimum required):

• Preferred: Bachelor’s Degree in a related science or technical field with 2 years of relevant experience.
• Minimum: High School Diploma with 4+ years of relevant experience in a regulated GMP environment.
• Additional qualifications such as Lean Six Sigma, ASQ certification, or other professional certifications are desirable.