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Genentech

Quality Assurance Specialist II (MQA)

Posted 5 Days Ago
Be an Early Applicant
In-Office
Hillsboro, OR
Mid level
In-Office
Hillsboro, OR
Mid level
The Quality Assurance Specialist II provides GMP support, manages batch records, resolves quality issues, and collaborates on quality initiatives.
The summary above was generated by AI

Hillsboro Technical Operations (HTO) is a drug product & finished goods manufacturing organization responsible for the reliable delivery of Roche’s commercial portfolio & pipeline products. The Quality organization at HTO comprises Quality Assurance, Quality Systems & Compliance, Quality Control, and Quality Engineering & Validation. Together, we produce millions of units of life-saving medicine every year to patients around the world.

The Opportunity

In this exciting role, you will be part of the Frontline Team (A Shift) in the Manufacturing Quality Assurance. You will act as a key Quality contact to manufacturing for floor support, batch record review and discrepancy management (Quality Incidents and Minor Deviation). You will partner with cross-functional stakeholders at the site. 

  • You will provide direct manufacturing Quality Assurance support for all GMP activities at HTO.

  • You will act as a key Quality contact to manufacturing for floor support, batch record review and discrepancy management (Quality Incidents and Minor Deviation) .

  • You will resolve routine Quality Assurance issues limited in scope and complexity following cGMP regulations.

  • You will meet assigned targets and timelines with minimal supervision

  • You will collaborate cross functional to ensure that all review activities are executed efficiently and effectively.

  • You will support Quality process improvement initiatives.

 

Who you are:
  • You hold a B.A./ B.S. degree (preferably in Life Science) with 2 - 4 years or MS degree (preferably in Life Science)  with 2 years of relevant bio/pharmaceutical manufacturing, quality, or engineering experience.

  • You are able to perform physical activity including, but not limited to lifting, standing for periods of time, and gowning

  • You have knowledge of cGMPs or equivalent regulations strongly preferred

  • You have experience reviewing manufacturing documentation

  • You are able to interpret and relate Quality standards for implementation and review

  • You are able to independently evaluate situations and propose potential solutions.

  • You are able to communicate clearly and professionally both in writing and verbally

  • You have flexibility in problem solving, providing direction and work hours to meet business objectives

The expected salary range for this position based on the primary location for this position of Hillsboro, OR is $67,000 - $125,000. Actual pay will be determined based on experience, level, qualifications, geographic location, and other job-related factors permitted by law. A discretionary annual bonus may be available based on individual and Company performance.  This position also qualifies for the benefits detailed at the link provided below.

Please note this role is eligible for relocation benefits.

Link to Roche/Genentech Benefits

Genentech is an equal opportunity employer. It is our policy and practice to employ, promote, and otherwise treat any and all employees and applicants on the basis of merit, qualifications, and competence. The company's policy prohibits unlawful discrimination, including but not limited to, discrimination on the basis of Protected Veteran status, individuals with disabilities status, and consistent with all federal, state, or local laws.

If you have a disability and need an accommodation in relation to the online application process, please contact us by completing this form Accommodations for Applicants.

Top Skills

Cgmps
Manufacturing Documentation
Quality Assurance Support

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