QA Specialist – II

  • Permanent
  • Anywhere

Website Intelliswift Software Inc

Intelliswift Software Inc

Company : Intelliswift Software Inc

Country: United States

Location : Frederick, Maryland

Post: Fri, 09 Sep 2022 15:24:29 GMT

Expires: Fri, 07 Oct 2022 23:59:59 GMT

Apply Job : Apply Online

—————————— Job Description ——————————

Role is 100% on site

*Successful candidate must meet the requirements for Covid vaccination PRIOR to starting

This position will work 4 – 10 hour days, Wednesday to Saturday, 0700 – 1730.

Responsibilities include (but are not limited to):

• Work with the Commercial Manufacturing, Quality Control, Materials Management and Facilities/Engineering departments as a Quality Assurance representative.

• Coordinate and facilitate Quality Assurance related production and production related activities, including:

o Assessment and closure of discrepancies, deviations and change controls requests.

o On-the-floor support Quality support to manufacturing and QC staff.

o Assessment and closure of laboratory investigations.

o Timely assessment and closure of batch and material hold events.

o Review of batch manufacturing and testing documentation for timely delivery of final product.

• Ensure that tests are performed, and products are manufactured in compliance with Kite specifications, regulatory and GMP guidelines.

• Support development of SOPs and review/approve SOPs to ensure quality objectives are met

• Review and approve test methods, manufacturing/quality control qualification/validation protocols and reports.

• Compile and verify all batch related documents into a final product lot disposition package.

• Perform/review and approve quality investigations of manufacturing deviations, GMP and quality system issues, non-conforming materials, and CAPA.

o Provide Quality Assurance support resolving material, in-process product, final product, environmental, facility and equipment manufacturing issues.

o Manage day-to-day activities for the initiation, tracking, and closure of non-conformances and CAPA activities.

o Provide periodic updates to management for deviations, GMP and system issues, non-conforming materials and products, and CAPA.

• Perform other duties as required.


• Bachelor’s degree in technical discipline (Biology/Chemistry/Microbiology/Engineering or related field) with a minimum of 3-5 years of experience in Quality Assurance or a GMP related field within a biotechnology, biologics, or pharmaceutical manufacturing facility.

• Must be proficient in Quality Systems, particularly associated with Operations and Exception Management/CAPA.

• Strong knowledge of GMP, SOPs and quality systems.

• Ability to effectively negotiate and build collaboration amongst individuals.

• Strong interpersonal, verbal and written communication skills.

• Experience with laboratory investigations, deviations, and CAPA.

• Experience with change control practices and strategies.

• General knowledge of aseptic manufacturing processes.

• Proficient in MS Word, Excel, Power Point and other applications.

• Ability to communicate and work independently with scientific/technical personnel.

• Comfortable in a fast-paced small company environment with minimal direction and able to adjust workload based on changing priorities.

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