Quality Assurance

4 days ago

Winchester, United States BCForward Full time
Job DescriptionJob Description

Job Title: QA Associate
Duration: 3 + Months (Temp to Hire)

Location: Winchester, KY 40391
Anticipated Start Date: 1/20/2025

(Please note this is the target date and is subject to change. BCforward will send official notice ahead of a confirmed start date.)

Job Type: Contract (40 hrs. a week)

Position Overview:
The QA Associate is responsible for the Quality support functions associated with the manufacturing of solid oral dosage products for a given business unit. The essential responsibilities associated with this position are oversight of the manufacturing operations (as dictated by cGMP, CFR, and  SOP) through document review/approval, real time monitoring/approval of manufacturing activities and testing/approval of in-process and finished product samples.

 

 Responsibilities Include, But Are Not Limited To:

  •  Recommend SOP and batch record changes as needed
  • Review proposed SOP revisions and provide feedback to management
  • Real-time audit of batch records in the production suites for completeness, documentation, calculation errors and conformance to critical process parameters
  • Perform room and equipment clearances per procedure following cleaning conducted by
  • production.
  • Perform microbial swabbing of equipment and room surfaces for environmental monitoring.
  • Maintain a full understanding of all Catalent SOPs and policies along with all cGMP and CFR guidance that are applicable to the manufacturing of solid oral dosage pharmaceutical
  • products.
  • Perform routine testing of in-process and finished product samples including particle size, bulk density, moisture analysis, appearance, and AQL testing real-time.
  •  Monitor production manufacturing areas for compliance to SOP/cGMP/batch record and safety requirements in order to identify and resolve routine errors and prevent possible deviations that affect production real-time.
  • Works cross functionally to assess impact for potential deviations and assist in identifying if an investigation is required.
  • Initiate deviation problem reports in Trackwise for issues discovered by QA, providing
  • sufficient detail of the incident so that a full investigation by the responsible department can be conducted.
  • Manage quality status of WIP and finished good materials on physical inventory and in
  • inventory system (JD Edwards)
  • Other assignments as needed within the scope of QA Associate training curriculum.
  • Assist in investigations for deviations by supporting data gathering and root cause analysis
  • Enforcement of GMP Compliance.
  • Promotes team work and good communication.
  • Provide training and coaching to manufacturing staff as needed
  • Support site process improvements (training, efficiency projects, implementation of CAPAs)
  • Supports customer complaint investigation by performing inspection of retains and complaint samples.

 

 Education or Experience:

 

  •  Bachelors Degree in related science or technical field preferred with 2 years prior work experience
  • Minimum of High School Diploma with 4+ years of relevant experience in a regulated GMP manufacturing environment.
  •  Additional qualifications desired are Lean Six Sigma, ASQ certification or other professional certification.

 

Knowledge/Skills Requirements:

  •  Familiarity with basic laboratory instrumentation
  •  Safe work habits
  •  Basic math and computer skills
  •  Good communication skills
  •  Ability to follow written and verbal instructions
  •  Able to work with limited supervision for routine tasks
  •  Excellent documentation and handwriting skills
  •  Proficient reading and comprehension skills
  •  Sound decision-making, technical and problem-solving skills
  •  Good time management skills
  •  Expert technical writing and problem-solving skills
  •  Good Laboratory Practices
  • Experienced with continuous improvement techniques

 

Benefits: BCforward offers all eligible employees a comprehensive benefits package including, but not limited to major medical, HSA, dental, vision, employer-provided group life, voluntary life insurance, short-term disability, long-term disability, and 401k. 

 

About BCforward:

Founded in 1998 on the idea that industry leaders needed a professional service, and workforce management expert, to fuel the development and execution of core business and technology strategies, BCforward is a Black-owned firm providing unique solutions supporting value capture and digital product delivery needs for organizations around the world. Headquartered in Indianapolis, IN with an Offshore Development Center in Hyderabad, India, BCforward’s 6,000 consultants support more than 225 clients globally.

BCforward champions the power of human potential to help companies transform, accelerate, and scale.  Guided by our core values of People-Centric, Optimism, Excellence, Diversity, and Accountability, our professionals have helped our clients achieve their strategic goals for more than 25 years.  Our strong culture and clear values have enabled BCforward to become a market leader and best in class place to work.

BCforward is 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 based on disability.

To learn more about how BCforward collects and uses personal information as part of the recruiting process, view our Privacy Notice and CCPA Addendum.  As part of the recruitment process, we may ask for you to disclose and provide us with various categories of personal information, including identifiers, professional information, commercial information, education information, and other related information.  BCforward will only use this information to complete the recruitment process.

This posting is not an offer of employment.  All applicants applying for positions in the United States must be legally authorized to work in the United States.  The submission of intentionally false or fraudulent information in response to this posting may render the applicant ineligible for the position.  Any subsequent offer of employment will be considered employment at-will regardless of the anticipated assignment duration.

Company DescriptionAbout BCforward:

Founded in 1998 on the idea that industry leaders needed a professional service, and workforce management expert, to fuel the development and execution of core business and technology strategies, BCforward is a Black-owned firm providing unique solutions supporting value capture and digital product delivery needs for organizations around the world. Headquartered in Indianapolis, IN with an Offshore Development Center in Hyderabad, India, BCforward’s 6,000 consultants support more than 225 clients globally.

BCforward champions the power of human potential to help companies transform, accelerate, and scale. Guided by our core values of People-Centric, Optimism, Excellence, Diversity, and Accountability, our professionals have helped our clients achieve their strategic goals for more than 25 years. Our strong culture and clear values have enabled BCforward to become a market leader and best in class places to work.

BCforward is an equal opportunity employer. All qualified applicants will rCompany DescriptionAbout BCforward:\r
\r
Founded in 1998 on the idea that industry leaders needed a professional service, and workforce management expert, to fuel the development and execution of core business and technology strategies, BCforward is a Black-owned firm providing unique solutions supporting value capture and digital product delivery needs for organizations around the world. Headquartered in Indianapolis, IN with an Offshore Development Center in Hyderabad, India, BCforward’s 6,000 consultants support more than 225 clients globally.\r
\r
BCforward champions the power of human potential to help companies transform, accelerate, and scale. Guided by our core values of People-Centric, Optimism, Excellence, Diversity, and Accountability, our professionals have helped our clients achieve their strategic goals for more than 25 years. Our strong culture and clear values have enabled BCforward to become a market leader and best in class places to work.\r
\r
BCforward is an equal opportunity employer. All qualified applicants will r

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