QA Specialist, Lab Services

The Quality Assurance Specialist will be part of the Laboratory Services Group to oversee all laboratory investigations, deviation reports, change controls from Chemistry, Micro and Spray laboratories for compliance with cGMP and company procedures with minimal supervision. The position will review changes requests related to analytical procedures and instruments qualification, review Standard Operating Procedures and analytical methods. The position will report quality metrics on laboratory investigations and perform trending of investigations.

• Review investigations, Change Control Requests, Standard Operating Procedures and Analytical Methods.
• Ability to make quality decisions based on cGMP, regulatory compliance, and site SOPs/documentation.
• Perform gap analysis of all quality related procedures to ensure there are no gaps present.
• Interacts with other departments and customers to address customer comments on Investigation and Deviations.
• Interact with departments to ensure timely revisions and approvals of the investigations.
• Reviews and approves methods, Document change notices and applicable SOPs for the QA Laboratory Services group.
• Assist with document retrieval during audits.
• Provide training to ensure effective use of the Trackwise system.
• Maintain and report quality metrics and trending of investigations.
• Review documents for compliance with company standards for formatting, review, approvals and implementation.
• Any other tasks as requested by management.
• Review and approve cGMP documentation as related to functions of QA Laboratory Services Group.
• Communicates key information to project management to assist with project timelines.
• Lead process improvements and projects within the company.

• Bachelor's degree in Chemistry or Biology required. 
• Prefer at least 3 to 4 years of relevant experience in the pharmaceutical industry on writing laboratory investigations and experience with GMP documentation review, Quality Systems, and Health Authority Regulations.