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Company

Original Job Post

BioSpace · 3 days ago

Sr. Quality Assurance Engineer

Thousand Oaks, CA

Full-time

Hybrid

Senior Level

10+ years exp

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Comp. & Benefits

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Responsibilities

Co-develop training materials for stability method transfers with CPO

Ensures activities are in line with budget and support evidence-based resource needs

Provides Quality oversight to CPO activities and results (A)

Quality approval of protocols and technical reports for method development (D)

Provides advice to inform Quality Plan (A)

Provides advice and expertise to inform development of technical training materials for method transfer (A)

Oversight of protocols and requirements to outsource testing to labs (A)

Approved method development, validation, and transfer reports

Robust change controls, CAPAs, and NCs

Successful CPO method stewardship deliverables

Method training materials

Reports to manager CPOQ Core in Thousand Oaks.

Key advisor to Core Technologies Lead

Advisor to Innovation and Development Leads

Advisor to site quality organizations

Advisor to Product Quality Leaders (PQLs)

Collaborate with and/or provide advice to Regulatory to inform submissions

Align with Attribute Sciences where similar networks or governances are established

Collaborate with External Supply Quality to ensure plans in place when receiving methods from a CMO or suppliers

Qualification

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Doctorate degreeMasters degree2 years of quality experienceAssociates degree8 years of quality experienceQuality ControlManufacturingBiotech IndustryPharmaceutical IndustryPhysical Methods DevelopmentForce MeasurementDimensional AnalysisCalibrationGLPCombination ProductsISO 14971ICH Q8ICH Q9ICH Q10ICH Q12ISO 13485EU Annex 121 CFR Parts 421 CFR Parts 82021 CFR Parts 21021 CFR Parts 211ISO 17025User Requirements AnalysisLeadershipCoordination

Required

Doctorate degree

Masters degree and 2 years of quality experience

Bachelors degree and 4 years of quality experience

Associates degree and 8 years of quality experience

High school diploma / GED and 10 years of quality experience

Preferred

10+ years of quality and manufacturing experience in biotech or pharmaceutical industry

Bachelors Degree in a Science Field

Experience in developing physical methods for combination products

Familiarity with force measurement equipment, dimensional analysis, calibration, and lab GLP

Leadership skills and the ability to coordinate multiple projects simultaneously

Familiar with combination products including applicable guidance, regulations and standards e.g. ISO 14971, ICH Q8, ICH Q9, ICH Q10, ICH Q12, ISO 13485, EU Annex 1, 21 CFR parts 4, 820, 210 and 211Working knowledge of calibration standard ISO 17025

Ability to discern user requirements for input to method development

Able to successfully manage workload to timelines

Benefits

Comprehensive employee benefits package, including a Retirement and Savings Plan with generous company contributions, group medical, dental and vision coverage, life and disability insurance, and flexible spending accounts.

A discretionary annual bonus program, or for field sales representatives, a sales-based incentive plan

Stock-based long-term incentives

Award-winning time-off plans and bi-annual company-wide shutdowns

Flexible work models, including remote work arrangements, where possible