QA Specialist - Goods and Manufacturing
5 - 7 years experience • Biotech/Pharma
Imp Note: This role is open because the client is building a new pilot lab that is being constructed.
A contract resource is sought to provide Quality Assurance oversight of validation related activities.
The candidate main duties will be to supportconstruction of a new pilot plant with focus on qualifying Facility, Utilities, and Process Equipment (small molecule oral API).
Additional duties include assisting other areas within the Foster City site (Analytical Lab Instruments, GMP Warehouses, Packaging/Labeling, and existing Pilot Plants). Must have prior experience in the pharmaceutical /biotech sector. The resource must have knowledge of equipment, computer systems, facilities, utilities validation and maintenance. Additional proficiencies in the use of Word, Excel, PowerPoint, Visio, Maximo, and Trackwise software are desirable. Essential duties include performing first-line QA review, providing comments, and following up with stakeholder to ensure regulatory compliance and procedures are being followed. Quality Assurance review is required for the following key job functions/activities:
· For validation lifecycle documents (risk assessments, URS, protocols, reports, trace matrix).
· For development and application of risk based validation methodology.
· For GMP equipment and computer system change records.
· For GMP Periodic Review (PR) activities (Equipment PRs and SOP PRs).
· For Deviation investigation, OOTs, and CAPAs.
· For creation and revisions of SOPs (operating, calibration, maintenance, routine monitoring)
· For calibration and maintenance related activities (GMP criticality assessments, asset information forms, and unscheduled Maximo work orders).
Knowledge, Experience and Skills:
· Experience with using risk-based qualification tools (PHA, FMEA).
· Must have strong knowledge of cGMP (FDA, EU and ICH) requirements and the ability to assess compliance risks.
· Experience with implementation/improvement of quality systems.
· Experience implementing and maintaining equipment and computer systems in a validated state.
· Experience providing QA oversight of facility changes, equipment qualification and lab system validation.
· Excellent communication skills (both oral and written) including the ability to effectively communicate across organizational levels and functions.
· Facilitate open communication and sharing of knowledge.
· Specific Education and Experience: Typically requires a BA or BS degree and minimum 5 years of relevant experience in related field or a MA or MBA degree and minimum 4 years of relevant experience.