Pfenex Inc.
  • 02-Oct-2018 to 01-Dec-2018 (PST)
  • San Diego, CA, USA
  • Contract

Reporting directly to the Quality Operations , as a key member of the Quality Organization, the QA Person In-Plant, (focus on device/combination product) is responsible for Quality Assurance in support of PFEnex product PF708. Strong QA experience in biosimilar biopharmaceutical and medical device/combination product environment from research and development to commercial.

 Interface closely with various departments to ensure that QA related activities at PFEnex, service providers are properly managed to support process/method transfer, disposition of products, achieve project goals, and timelines.  We are interested in candidates with a proven track-record of successfully and efficiently integrating activities and perspectives across functions to achieve our goal of delivering Quality cost-effective therapies that enable access to patients who need them

 

ESSENTIAL DUTIES AND PRIMARY RESPONSIBILITIES

 

  • Provide Quality oversight to contract service provider, identify GxP quality risks and present integrated risk management solutions to Project team and Quality leadership team.
  • Provide Person in the Plant presence through development and supply of GMP materials that meet PFEnex and industry compliance standards
  • Evaluate and track on site/ on the floor observations
  • Issue, review and /or approve labeling issued to Manufacturing
  • Review and approve GMP documentation (protocols, technical reports, specifications, test methods, URS, SOPs. IQ, OQ, PQ qualification documents, FAT, SAT, SOPs, tech transfer, risk assessments)
  • Review /approve master batch records, executed batch records, test data package and associated documents
  • Perform product disposition and review/approve CoA.
  • Review /approve validation protocols/reports, related documents and provide general oversight of validation activities
  • Collaborate and support investigations, change management, product related deviations, OOS and CAPAs and help drive to closure
  • Provide/escalate issues and recommendations to Pfenex Quality Management
  • Plan, schedule, conduct and provide report for internal and external audits at contract service providers including contract labs and vendors
  • Perform risk assessment as part of supplier qualification process, including management of testing of components and devices for cGMP compliance
  • Support other cGMP QA efforts
  • A monthly qualitative accurate (metric) update demonstrating progress and/or challenges in key project areas. Support with quantitative data
  • Partner with Manufacturing, QC, workstream team to ensure project timelines are achieved
  • Facilitate meetings with CSP and with workstream team and other teams, members as required by project needs
  • Collaborate and partner with Process Development, Analytical and Manufacturing Team, Program Management, Quality Control, Supply Chain, Regulatory and CMC in support of PF708 operational and registration activities.
  • Support regulatory inspection, due diligence audits, serving as QA escort, as needed
  • Review relevant sections of the regulatory filing and support Quality response preparations
  • Participate in pre-approval inspection readiness of internal systems and for contract service providers
  • Prepare trending/metrics for Quality management review
  • Participate as required, in the evaluation of Pfenex Quality System and processes for optimization and continuous improvement
  • Other duties as assigned or required.

JOB SKILLS, ABILITIES AND QUALIFICATIONS

 

A minimum of a Bachelor of Science degree in life sciences or other relevant biologic, chemistry, biochemistry, engineering discipline required; Master's degree preferred.

  • 10+ years of Pharmaceutical/Biopharmaceutical Quality, Compliance medical device, combination product experience in support of clinical/commercial manufacturing of Biologics, Sterile Fill finish required
  • 5+ years quality engineering experience which must be in the medical device/combination product industry with FDA experience
  • 5+ years of managing and leading others required
  • Knowledgeable of GxP environment cGMP, GLP, GCP environments and regulations experience required.
  • Knowledgeable of US standards 21CFR210, 21CFR211, 21CFR11, 21CFR820 and ICH Quality Guidelines, Quality System Regulations/Good Manufacturing Practices, ISO 13485, ISO 9001, ISO 14971
  • ASQ, Black Belt/Green Belt certifications a plus.
  • Ability to travel up to 40% (US and Internationally)
  • Ability to work flexible work schedules.
  • Excellent computer, verbal, and written communication skills
  • Passion for manufacturing with an on-floor presence to advance product quality standards
  • Ability to work in a team environment
  • Innovative approach to problem-solving, an integrated view of business/scientific issues, and a strong work ethic.
  • Proven ability to work in a lean organization and creatively tackle problems.
  • Work independently in a matrix environment and manage multiple tasks simultaneously.
  • Experience in medical device and combination product organization
  • Experience with biopharmaceutical product PD, research, clinical, and commercial manufacturing
  • Significant experience with MS Office Suite; Project, Visio, LIMS, and EDMS.
Pfenex Inc.
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