Sr. QA Specialist

Proclinical is currently recruiting for a Sr. QA Specialist with a pharmaceutical company located in Santa Monica, CA.

Job Responsibilities:

• Support strong partnership with across network site QA groups to ensure global RM and Regents QA operations are continuously improved
• RM documentation review and ensure resolution of issues to release raw materials
• Review and approval of raw material OOS, Deviations and CAPAs
• Disposition of raw materials lot
• Review and approval of Change Controls and ensure proper maintenance and approval of cGMP documents
• Ensure change controls are initiated, evaluated and implemented appropriately for all regulated changes
• Support quality walk through of QC lab for RM and Reagents
• Support regulatory inspections, internal audits, and external audits from partners
• Acts as an Analytical QA subject matter expert in support of regulatory inspections and internal audits
• May conduct or serve as a lead/coordinator of investigations and corrective/preventative actions
• Review and approval of technical (analytical) protocols and reports as appropriate
• Review and approve analytical validation efforts from phase 1 through commercial and highly experienced in method validation and method transfer guidelines per ICH and USP
• Review and improve existing quality procedure workflows, identifies areas of improvement for efficiency and compliance, and leads implementation efforts in collaboration with cross-functional stakeholders
• Serve as QA project lead, leads complex quality investigations/deviations, and independently authors or approves concise quality investigation reports with appropriate corrective action and preventive actions (CAPA)
• Participate in Material Review Board meetings to ensure non-conforming material is appropriately dispositioned
• Support Management Review activities and oversee trending of key quality, raw material and GMP metrics
• Support deviation investigations from Control Testing Laboratories
• Provide QA consultations to support RM and Reagents QC on the floor process.

Skills and Requirements:

• 5+ years of experience in a GMP environment with MS degree in the biological sciences or related field
• In-depth knowledge of and ability to apply GMP in conformance to US, EU and ROW standards
• Proficient in cGMP regulations, quality systems and regulatory requirements.
• Experience writing, evaluating and closing investigations, CAPAs and change control records
• Experience with conducting and managing internal and external audits
• In-depth understanding and application of qualification and validation principles, concepts, practices, and standards
• Ability to effectively negotiate and build collaboration amongst individuals
• Demonstrated ability to develop, coach, and mentor key employees
• Proficient in MS Word, Excel, Power Point and other applications
• Excellent interpersonal, verbal and written communication skills are essential in this collaborative work environment
• Ability to recognize deviations from accepted practice and apply knowledge of current Good Manufacturing Practices (CGMP) on a daily basis
• Advanced technical writing and excel skills are highly desired for creating and presenting reports
• Ability to work independently and effectively coach peers in a high-paced environment with tight timelines, while maintaining accuracy and quality
• Ability to effectively generate metrics, and present; data, findings, and improvement initiatives/projects to QA and cross-functional leadership
• A relevant background in Quality Control or Analytical Development with a role as a supervisor or manager is highly desired

If you are having difficulty in applying or if you have any questions, please contact Catherine Nguyen at 215-531-5643.

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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