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Manager, Quality Assurance
STA Pharmaceutical San Diego, CA
Other 6 Months Ago
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STA Pharmaceutical is Hiring a Manager, Quality Assurance Near San Diego, CA

Overview

The Manager provides support in strict accordance to Standard Operating Procedures and cGMP guidelines for small molecule manufacturing services. Assists with implementing and managing the Quality Systems, Document Control functions, material and batch release, training program, internal/external audit program, tracking and trending of non-conformances, and developing and implementing corrective actions. The incumbent interacts with cross-functional groups to ensure that high quality standards are maintained during the process development and scale-up work.

Qualifications

Experience / Education

  • Bachelor’s degree in a scientific discipline or equivalent and 2 years of a role in Quality Assurance in addition to 5 years of experience in the pharmaceutical industry.
  • Experience in supporting API development, ideally spanning early phase development.
  • CMO/CRO experience is highly desirable.

Knowledge / Skills / Abilities:

  • Demonstrated in-depth understanding of cGMP manufacturing for biopharmaceutical products.
  • Thorough knowledge of cGMP’s, ICH and relevant FDA guidelines, and understanding of process chemistry and analytical techniques.
  • Ability to interact well with diverse groups, and maintain collaborative working relationships with internal and external partners.
  • Ability to function with a sense of urgency.
  • Possess strong organizational and interpersonal skills while maintaining high quality and efficiency standards.
  • Assist in efficiently addressing deviations, investigations and corrective actions to ensure compliance and completion within a reasonable time frame.
  • Establish a good working relationship with clients and support the delivery of intermediates/API in a timely fashion.
  • Excellent written communication skills with the ability to write SOP’s concisely and accurately.
  • Skilled in using multiple computer programs (MS Office Suite, MS Project, MS Visio and Adobe Acrobat).
  • Ability to communicate with management and clients is essential.

Physical Requirements:

  • Must be able to work in an office environment with minimal noise conditions
  • Must be able to wear appropriate PPE during production inspections/audits and be comfortable around hazardous materials (i.e. Chemicals)
  • Must be able to work in environment with variable noise levels
  • Ability to stand/sit/walk for long periods of time
  • Ability to Lift 10 lbs routinely
  • Ability to crouch, bend, twist, and reach
  • Ability to push/pull 10 lbs routinely/often/occasionally
  • Clarity of Vision
  • Ability to identify and distinguish colors
  • Must be able to perform activities with repetitive motions
  • Ability to climb Ladders/Stairs/Scaffolding
  • Ability to work in variable temperatures high to freezing
  • Inside/outside working conditions

An Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, or protected veteran status and will not be discriminated against on the basis of disability

This job description does not state or imply that the above are the only duties and responsibilities assigned to this position. Employees holding this position will be required to perform any other job-related duties as requested by Management.

Responsibilities

Essential Job Functions:

  • Develop, implement and maintain quality assurance documentation systems, procedures, and compliance programs that support production of GMP products.
  • Review multi-product Batch Production Records.
  • Maintain material lot files, databases and spreadsheets.
  • Review deviations, investigations and corrective actions to ensure compliance and completion within a specific time frame.
  • Review analytical data packages in support of raw materials, starting materials, intermediates and API release.
  • Author, revise, review and implement Standard Operating Procedures.
  • Assist with/Perform internal/external audits.
  • Review and approve COA, stability protocols, validation reports
  • Collaborate with other functional groups and accept other duties and responsibilities as needed.
  • Perform line clearance in GMP production rooms.
  • Review and approve equipment data and reports such as calibration and qualification.
  • Manage the Vendor Management program to qualify vendors in support of production.
  • Establish, review and approve quality agreements with clients and vendors.

Job Summary

JOB TYPE

Other

POST DATE

09/21/2022

EXPIRATION DATE

12/12/2022

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If you are interested in becoming a Manager Quality Assurance, you need to understand the job requirements and the detailed related responsibilities. Of course, a good educational background and an applicable major will also help in job hunting. Below are some tips on how to become a Manager Quality Assurance for your reference.

Step 1: Understand the job description and responsibilities of an Accountant.

Quotes from people on Manager Quality Assurance job description and responsibilities

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Step 2: Knowing the best tips for becoming an Accountant can help you explore the needs of the position and prepare for the job-related knowledge well ahead of time.

Career tips from people on Manager Quality Assurance jobs

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