Quality Assurance Specialist

4 weeks ago

Winchester, Kentucky, United States BCforward Full time
Job Summary

We are seeking a highly motivated Quality Assurance Specialist to join our team at BCforward. As a Quality Assurance Specialist, you will be responsible for ensuring the quality and compliance of our manufacturing processes.

Key Responsibilities:

  • Recommend and implement changes to Standard Operating Procedures (SOPs) and batch records as needed
  • Review proposed SOP revisions and provide feedback to management
  • Conduct real-time audits of batch records in 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, as well as all cGMP and CFR guidance 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 in real-time
  • Monitor production manufacturing areas for compliance to SOP/cGMP/batch record and safety requirements to identify and resolve routine errors and prevent possible deviations that affect production in real-time
  • Work cross-functionally to assess the impact of 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 the 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
  • Enforce GMP Compliance
  • Promote team work and good communication
  • Provide training and coaching to manufacturing staff as needed
  • Support site process improvements (training, efficiency projects, implementation of CAPAs)
  • Support customer complaint investigation by performing inspection of retains and complaint samples

Requirements:

  • Education or Experience: (Minimum required to perform job)
  • Preferred - Bachelors Degree in related science or technical field in combination with 2 years prior relevant work experience
  • Minimum of High School Diploma in combination with 4+ years of relevant work experience in a regulated GMP manufacturing environment
  • Additional qualifications desired are Lean Six Sigma, ASQ certification or other professional certifications

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.

Interested candidates please send resume in Word format. Please reference job code 229730 when responding to this ad.

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