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