QA Specialist I, GMP Manufacturing

QA Specialist I, GMP Manufacturing - Contract - Philadelphia PA

Join our client and play a key role in maintaining top-tier quality standards! If you have a keen eye for detail and a passion for compliance, this could be your perfect opportunity.

Proclinical is seeking a QA Specialist I to provide quality oversight in manufacturing operations, ensuring adherence to established procedures and regulatory compliance.

Primary Responsibilities:

In this role, you will collaborate with cross-functional teams to address quality issues, support process improvements, and act as the primary quality contact for clients. This position involves reviewing and approving batch records, non-conformances, deviations, and CAPAs, as well as preparing Certificates of Analysis for batch release.

Skills & Requirements:

• Strong knowledge of cGMP requirements and regulatory compliance.
• Proficiency in root cause analysis techniques.
• Experience in writing, reviewing, and approving laboratory investigations, deviations, and CAPAs.
• Competence in using Microsoft Word, Excel, and Access.
• Excellent attention to detail and ability to record data accurately.
• Strong judgment and problem-solving skills.
• Effective verbal and written communication skills.
• Ability to work collaboratively within a team and exhibit strong interpersonal skills.
• Bachelor's degree in a science-related field or equivalent experience.
• Commitment to maintaining data integrity and operational excellence.

The QA Specialist's responsibilities will be:

• Review and approve low-risk non-conforming events, deviations, and CAPAs.
• Review and approve pre-executed and executed manufacturing batch records.
• Prepare manufacturing release checklists and Certificates of Analysis (COAs).
• Stay updated on GXP regulations, including FDA, EU, and other regulatory guidance.
• Collaborate with manufacturing management to provide quality perspectives on routine operations.
• Address and document quality-related findings, reporting them to management.
• Work with project teams to ensure manufacturing records meet project requirements.
• Compile and review raw data, batch records, and test results in compliance with cGMP standards.
• Revise Standard Operating Procedures (SOPs) as needed.
• Review and approve document change requests.
• Participate in quality and process improvement initiatives.
• Coordinate and execute manufacturing suite inspections.
• Support internal audits, client audits, supplier audits, and regulatory inspections.
• Conduct on-site visits with clients as required.
• Perform visual inspection qualification for final product defect detection, if selected.
• Contribute to departmental goals and ensure compliance with applicable regulations and standards.

If you are having difficulty in applying or if you have any questions, please contact Mike Raletz at m.raletz@proclinical.com

If you are interested in applying to this exciting opportunity, then please click 'Apply' or to speak to one of our specialists please request a call back at the top of this page.

Proclinical is a leading life sciences recruiter focused on finding exceptional people and matching them with the finest positions across the globe. Proclinical is acting as an Employment Agency in relation to this vacancy.

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