Senior Quality Assurance Officer (Product Release Team)
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Senior Quality Assurance Officer (Product Release Team)
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By joining Bio-Techne, you’ll join a company with a powerful and positive purpose of enabling cutting-edge research in Life Sciences and Clinical Diagnostics. Bio-Techne, and all of its brands, provides tools for researchers to further treat and prevent disease worldwide.
Reports To: QA Team Leader
Location: Bristol, UK
Position Summary
The Senior QA Officer will work alongside the QA Team Leader to coordinate and lead the daily operations of the business maintaining compliance to the QA requirements across all product types and business areas. Responsible for leading activities that support CGT manufacture and weighing schedule. Responsible for managing the Campaign reviews. The Senior QA Officer will mentor and coach other QA Officers in quality requirements and business practices.
Reporting to the QA Team Leader the Senior QA Officer will be a highly collaborative and proficient individual with excellent communication skills.
Essential Duties And Responsibilities
* Leading activities that support the CGT manufacturing and weighing schedules.
* Lead the review, approval and release of Batch Production Records and Quality Control testing data.
* Non-conformance: Coordinate and approve/manage to completion any non-conformances, deviations and out of specifications.
* CAPA: Coordinate and approve/manage to completion any CAPA raised. Ensure adequate root cause analysis has been conducted and any corrections or corrective/preventative actions have been implemented correctly.
* Documentation Management: Writing, reviewing, and approving internal procedures. Release and issuance of procedures and archiving previous revisions.
* Change Control: Review and approval of change controls related to CGT manufacturing and product quality, ensuring all changes are assessed and implemented correctly.
* Experienced internal auditor for ISO 9001, ISO13485 or cGMP.
* External/Customer Audits: Support preparation activities and backroom activities during external/customer audits.
* Work closely with Quality, Manufacturing, Supply Chain and Facilities teams to identify and support the Quality System compliance and customer needs. Uses initiative and adapts to shifting priorities.
* Training: Lead internal quality related training sessions for the business.
* Experienced in Product disposition and release.
* Experienced in the critical review of CAPA / non-conformances / deviations / OOS.
* Experienced in documentation management systems and change control processes from a Quality Assurance perspective.
* Coach and mentor team members on quality assurance and business requirements including best practices.
* Foster and support a culture of high performance, creativity, teamwork and Bio-Techne’s EPIC values.
* Any other task as required by the business.
Bio-Techne is committed to product quality, customer satisfaction, continued improvement, minimising environmental impacts and conserving natural resources. Environmental and quality management is an integral core value and vital part of the Bio-Techne culture.
Why Join Bio-Techne
* We offer competitive wages along with extensive benefits for employees and their families.
* We invest in our employees’ financial futures through retirement programs and an employee stock purchase plan.
* We help our employees develop their careers through mentorship, promotional opportunities, training and development, internship programs, and more.
* We offer an international and diverse working environment, enriched by employee resource groups; volunteer and charity events; and employee events that build a culture of caring and belonging.
* We foster a culture of empowerment and innovation, where employees feel valued and encouraged to bring their new ideas to the table.
Bio-Techne 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, disability, or status as a protected veteran.
To protect the interests of all, Bio-Techne will not accept unsolicited resumes from any source other than a candidate application. Any unsolicited resumes sent to Bio-Techne will be considered Bio-Techne property.
Seniority level
* Seniority level
Mid-Senior level
Employment type
* Employment type
Full-time
Job function
* Job function
Quality Assurance
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