QA Associate

TN United Kingdom; Winchester; On-site; GBP 30,000 - 50,000; Full time

Job summary

An established industry player is seeking a dedicated QA Associate to ensure quality support functions in the manufacturing of solid oral dosage products. The role encompasses oversight of manufacturing operations, real-time monitoring, and testing of in-process and finished products. Ideal candidates will have a Bachelor’s degree or significant experience in a regulated GMP environment, with additional qualifications like Lean Six Sigma being a plus. Join a collaborative team where your contributions will enhance product quality and compliance in a dynamic setting.

Qualifications

• Bachelor’s Degree in a related science preferred, or High School Diploma with 4+ years experience.
• Lean Six Sigma or ASQ certification is desirable.

Responsibilities

• Perform real-time audits of batch records for compliance and accuracy.
• Conduct microbial swabbing for environmental monitoring.
• Initiate deviation reports and assist in investigations.

Skills

Quality Assurance

cGMP Compliance

Document Review

Environmental Monitoring

Root Cause Analysis

Education

Bachelor’s Degree in a related science

High School Diploma

Tools

Trackwise

JD Edwards

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 and approval, real-time monitoring and approval of manufacturing activities, and testing and 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. Perform real-time audits of batch records in production suites for completeness, documentation accuracy, calculation errors, and conformance to critical process parameters.
4. Conduct room and equipment clearances following cleaning procedures conducted by production.
5. Perform microbial swabbing of equipment and room surfaces for environmental monitoring.
6. Maintain comprehensive understanding of all SOPs, policies, cGMP, and CFR guidance applicable to manufacturing solid oral dosage pharmaceuticals.
7. Perform routine testing of in-process and finished product samples, including particle size, bulk density, moisture analysis, appearance, and AQL testing in real-time.
8. Monitor production areas for compliance with SOPs, cGMP, batch records, and safety requirements to identify and resolve errors and prevent deviations.
9. Collaborate cross-functionally to assess the impact of potential deviations and determine if investigations are necessary.
10. Initiate deviation reports in Trackwise with detailed incident descriptions for investigation.
11. Manage the quality status of WIP and finished goods in physical inventory and the JD Edwards system.
12. Assist in investigations for deviations by supporting data collection 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 site process improvements, including training, efficiency projects, and CAPA implementation.
17. Assist in 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 work 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.