QA Compliance Specialist

Proclinical is currently recruiting for a QA Compliance Specialist with a leading pharmaceutical company located remotely. The role is an initial 6 month contract with a high probability of extension.

Job Responsibilities:

• Review batch records, specifications, SOPs, data, and other supporting documentation related to the manufacturing, testing, packaging, and labeling processes to assess compliance with the regulatory submissions.
• Determine source of any differences or issues found upon review of the documentation.
• Collaborate with cross-functional departments to resolve discrepancies and ensure compliance.
• Assess discrepancies for product impact and author justifications where possible.
• Foster communication with key stakeholders in order to properly plan and prioritize workloads based on potential impact to supply.
• Identify and implement continuous improvement initiatives.
• Support QA project initiatives for a broad range of topics as the group evolves.
• Perform other responsibilities as requested.

If you are having difficulty in applying or if you have any questions, please contact Max Kelly at (+1) 312-270-1613 or m.kelly@proclinical.com.

Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.

Proclinical Staffing is an equal opportunity employer.

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