Position Summary :
We are seeking a highly motivated QA Manufacturing Specialist I / II at our state-of-the-art commercial manufacturing facility in Patriot Park, Durham, NC.
You will have the unique opportunity to help build our site processes and culture as we ramp up to full manufacturing capacity.
We embrace KBI’s values of learning and growth, high standards, collaboration, and trust and respect to solve problems and continuously improve.
As a center of excellence, our site enables real-time quality and process monitoring through paperless records with integrated automation.
We are looking for a critical thinker who is comfortable tackling new challenges / unknowns and utilizing a risk-based approach. We hope you join us!
Position Responsibilities :
Be an on-the-floor quality partner working with the manufacturing team during operations
Work with manufacturing and other groups to escalate and resolve deviations and other compliance issues
Conduct QA walkthroughs
Participate in safety walkthroughs
Participate in process improvements
Attend relevant meetings in support of manufacturing operations
Review electronic batch records and logbooks
Provide feedback on facility response for unplanned events
Other tasks and projects as assigned
Work 12-hour shifts (2-2-3 schedule, day shift)
Position Qualifications :
MQA Specialist I
- High School diploma or equivalent.
- Degree progression preferred. GMP / regulated industry / laboratory experience is required (approximate 1-3 years).
- Demonstrated ability to work in a team environment.
- Demonstrated ability to understand the manufacturing process.
- Ability to perform routine core MQA responsibilities.
MQA Specialist II
- Associate degree / bachelor’s degree strongly preferred or appropriate years of experience (approximate 3-5 years).
- Demonstrated ability to work in a team environment and strong communication skills within all levels of an organization.
- Demonstrated ability to represent Quality on interdepartmental meetings.
- Demonstrated knowledge of technical documents.
- Ability to support internal and external audits.
- Demonstrated ability to train employees on Quality subjects.
- Ability to track and trend department metrics
Salary Ranges :
MQA Specialist I : $54,000 - $74,300
MQA Specialist II : 66,966 - 92,077
Salary range provided per current averages and expectations. The salary and job title for this opening will be based on the selected candidate’s qualifications and experience and may be outside this range.
KBI has a robust total rewards strategy which includes an annual bonus structure for all employees, medical, dental, and vision coverage, paid PTO and holidays, Sabbatical program, 401K matching with 100% vesting in 60 days and employee recognition programs.
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We are seeking a highly motivated QA Manufacturing Specialist I/II at our state-of-the-art commercial manufacturing facility in Patriot Park, Durham, NC. You will have the unique opportunity to help build our site processes and culture as we ramp up to full manufacturing capacity. Be an on-the-floor...
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