Champion regulatory compliance and quality assurance in a pivotal QA Specialist III role.

Proclinical is seeking a QA Specialist III for a contract position located in the US.

Primary Responsibilities:

The successful candidate will work as part of an inter-departmental team to implement and maintain effective quality practices for both new and existing clients. You will act as the primary Quality Assurance representative for major clients, ensuring compliance with current Good Manufacturing Practices (cGMP) and regulatory standards.

Skills & Requirements:

• Strong knowledge of FDA and EU cGMP requirements.
• Proficiency in root cause analysis techniques.
• Experience in writing, reviewing, and approving investigations, deviations, and CAPAs.
• Familiarity with GLP, cGMP, PTC guidelines, and ISO17205 standards.
• Excellent interpersonal, verbal, and written communication skills.
• Ability to work effectively as part of a team and independently.
• Proficiency in Microsoft Office applications (Word, Excel, Outlook, Access).
• Strong analytical and problem-solving skills, with attention to detail.
• Bachelor's degree in a science-related field or equivalent experience.
• Commitment to maintaining compliance with FDA and worldwide quality regulations.

The QA Specialist III's responsibilities will be:

• Review and approve Certificates of Analysis (CoAs), deviations, and CAPAs.
• Conduct thorough reviews of manufacturing batch records in accordance with cGMP, GLP, and internal procedures.
• Ensure investigations and deviations are properly documented, investigated, and resolved.
• Approve manufacturing CoAs, product specifications, and label specifications.
• Stay updated on changes to GXP regulations, including FDA, EU, and other regulatory bodies.
• Collaborate with manufacturing management to provide quality perspectives on operations and support systems.
• Address and escalate issues as necessary, ensuring proper resolution.
• Work with project teams to translate project requirements into manufacturing records.
• Write, review, and revise Standard Operating Procedures (SOPs) as needed.
• Participate in internal and client audits, supplier audits, and regulatory inspections.
• Review and approve change controls, document change requests, and technical transfers.
• Support equipment validation processes, including IQ, OQ, and PQ reviews.
• Contribute to quality and process improvement initiatives.
• Act as the QA contact for on-site client visits and coordinate project execution.
• Ensure compliance with all applicable regulations, standards, and company policies.

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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