Sr. QA Specialist

Highly Competitive Salary
  1. Permanent
  2. Good Manufacturing Practice (GMP), Good Distribution Practice (GDP), Good Clinical Practice (GCP)
  3. United States
Santa Monica, USA
Posting date: 10 Jun 2020
This vacancy has now expired

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.