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Supervisor, Quality Assurance - (Science & Quality System Operation Process Background) Madison, WI

  • Location: Madison, Wisconsin
  • Type: Direct Hire
  • Job #2818

Looking to further your QA career with a leader in Biotech? If you have a scientific background and significant experience in quality system operation processes, we have the perfect Supervisor, Quality Assurance role for you!

What You'll Do:
As part of the Product Quality Assurance team, you will lead a team of Quality Assurance Specialists and/or Scientists as well as apply your quality and scientific knowledge to provide product support as an individual contributor.

We are looking for someone with a scientific background and quality experience that includes working knowledge and direct application experience of the requirements of quality assurance systems in a manufacturing and/or product or process development environment. This role will include:
– Support QA Management in establishing direction and leadership for and participating in QA’s role in supporting the company's catalog and custom products. 
– Direct and oversee the involvement of QA Scientists and Specialist/Senior Specialist staff.
– Ensure that QA staff support business, regulatory, and quality system requirements.
– Provide direction to staff and resource allocation as needed.
– Ensure that QA fulfills its role in verifying product claims and supporting external customer needs.
– Utilize key performance indicators to identify areas for improvement and to justify departmental resources.
– Ensure that records are produced and maintained according to procedural requirements.
– Provide daily support for QA-owned processes, including but not limited to batch record review, deviations, investigations, quality holds, product stability program, New Product Realization, and review/approval of work instructions, labeling, and certificates of analysis.
– Recruit, manage and develop staff to meet departmental and business needs. Provide coaching, career development and performance expectations to staff in performance review process.
– Represent Quality Assurance on cross-functional teams and in interactions with other departments.
– Work with QA Director and QA Manager to develop departmental staffing, budget, training and capital expense plans annually or as necessary and required to meet departmental and business needs.
– Creation, review and approval of product batch records, work instructions, labels, and product literature, process changes, investigations, deviations, and corrective/preventive actions, as needed.
– Assure that new products meet their design requirements and performance requirements through participation in new product development teams.
– Make decisions regarding product quality and product release, including nonconforming product situation, quality hold, and general disposition planning.
– Establish and approve shelf-life assignments for catalog and custom products in cooperation with Manufacturing, Marketing and R&D staff. This includes approval of study design, data review, and Process Change approval.
– Demonstrates inclusion through their own words and actions and is accountable for a safe workspace. Acts with kindness, curiosity and respect for others.
– Understands and complies with ethical, legal and regulatory requirements applicable to our business.

OCCASIONAL DUTIES:
– 
Represents the company in discussions/interactions with external customers and suppliers.
– Present updates or training on projects/programs to leadership or company employees as required.
– Organize, facilitate, or lead cross departmental teams.
– Participate in training programs in areas of expertise and experience.

What You'll Bring:
– A B.S. or M.S. plus 8 years experience, or a Ph.D. plus 5 years experience in a scientific area such as molecular biology, cell biology, proteomics or chemistry, or Quality Assurance related field.
– Demonstrated experience and technical understanding of development, manufacturing and quality assurance processes for life science research products. Ability to troubleshoot, define problems and develop solutions, and bring improvements to bear in a technical setting.
– Demonstrated experience in achieving results in a cross functional environment.
– Advanced communication skills, both verbal and written.
– Independent self-starter with proven analysis planning, leadership, and project management skills.

PREFERRED QUALIFICATIONS (We encourage you to apply even if you don't meet those listed below):
– Demonstrated skills in the recruitment, coaching and development of staff to meet organizational needs.
– Experience in professional QA organization.
– Understanding of ISO13485 and QSR Quality System requirements.
– Demonstrated results and experience in an ISO, cGMP, or other regulated environment.

 

Apply Now and catapult your career forward!
Questions? Contact Ginger Auchter directly at Ginger@CarexScientific.com

Carex Consulting Group is an equal opportunity employer. We are committed to equal employment opportunity regardless of race, color, ancestry, religion, sex, national origin, sexual orientation, age, marital status, disability, gender identity or Veteran status.

 

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