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Quality Technical Manager Job

Eingestellt von Yoh

Gesuchte Skills: Support, Engineering

Projektbeschreibung

QUALITY TECHNICAL MANAGER needed for a CONTRACT opportunity with Yoh's client located in South San Francisco, CA.

TOP SKILLS SHOULD YOU POSSESS:

- Quality
- Biopharmaceutical
- Batch record

WHAT YOU'LL BE DOING:

- QA - Lot Review - Commercial Bulk Manufacturing. Review of all batch records, deviation reports, chromatograms, batch reports and other quality records to support the lot release of commercial bulk products.
- Work on other projects to support quality managers as needed in Quality Risk Assessment, Audit tracking and closure, support of regulatory filings, commissioning, change control, metrics and other possible areas.
- The position will assist in the preparation of release packages for approval with the Site Managers and within established standard lead times. The position will be required to work extensively and collaboratively with under the Site Managers direction in order to resolve issues as identified during the disposition process. The position is in South San Francisco, CA External Quality Operations and has a normal Monday-Friday business hours. The position supports CMO operations.
- Provide Quality support for products manufactured at Contract Manufacturing Organization (CMO's) to ensure compliance with cGMP regulations and standards.
- Review of batch record review activities to ensure that products are dispositioned in accordance with regulatory requirements, cGMP's and Genentech policies and procedures, within standard lead times.
- Interfacings with appropriate departments or manufacturing plants to ensure that lot disposition items are completed.
- Prioritize workload to meet department and organizational targets and timelines.
- Manage competing priorities and allocate, adjust, and optimize assigned department resources.
- Identify, design, and implement process and system improvements.
- Troubleshoot and direct the resolution of Quality issues by fostering effective interdepartmental and cross-functional partnerships.
- Manage all required activities to support release of commercial product including review of master process documentation, batch record review, resolution of investigations, and assessment of change controls.
- Perform any other tasks as requested by Management to support Quality oversight activities.
- Support creation of Annual Product Reviews, product complaint investigations, and other quality functions as required.
- Interfacings with appropriate departments or manufacturing plants to ensure that lot disposition items are completed.
- Notification to Management for all known delays in meeting established standard lead times or any potential significant quality issues.
- Interfacing with QA Site Managers to ensure that final batch review activities are completed.
- Performing a review of investigations for potential cumulative effect to a batch history record.

WHAT YOU NEED TO BRING TO THE TABLE:

- B.A. or B.S. degree (preferably in life sciences or engineering) and 7-11 years of experience in the large and/or small molecule related industry, or an equivalent combination of education and experience.
- At least 1 year lot review or batch release experience in filling or biochemical operations.
- Hands on expertise in one or more technologies in biopharmaceutical drug substance with working knowledge of facility, equipment and process qualification/validation.
- Working experience with risk management concepts and tools.
- Sound knowledge of cGMPs and relevant international regulatory requirements and experience in Quality Assurance with ability to accurately interpret and implement quality standards.
- Well-developed teamwork, collaboration and negotiation skills and ability to communicate clearly and professionally both verbally and in writing.
- Demonstrated problem solving and decision making skills.

OPPORTUNITY IS CALLING, APPLY NOW!

RECRUITER: Hannah Cihlar

Yoh, a Day & Zimmermann company, is an Equal Opportunity Employer, M/F/D/V. Click here to contact us if you are an individual with a disability and require accommodation in the application process.

J2W: CLINICAL

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Ref:

SFSF: LS

Projektdetails

  • Einsatzort:

    South San Francisco, Vereinigte Staaten

  • Projektbeginn:

    asap

  • Projektdauer:

    Keine Angabe

  • Vertragsart:

    Contract

  • Berufserfahrung:

    Keine Angabe

Geforderte Qualifikationen

Yoh