Supervisor, Quality Assurance -2nd Shift

Our Work Matters
At Kindeva we make products that save lives, ensuring better health and well-being for patients around the world.
The Impact You Will Make
The Supervisor-Quality Assurance plans and coordinates the activities of the Quality Assurance colleagues to support P&I production activities. Responsibilities include ensuring quality inspections are consistent with established standards and Batch Records requirements, adherence to SOP’s and GMP’s regulations. The incumbent will supervise quality employees engaged in QA activities and support P&I on identification and resolution of issues.
Role Responsibilities

• Supervision/coordination of duties such as AQL
sampling, line clearances, label printing,
product/component segregation, product/component
labeling and batch record issuance on shift
• Assist P&I Supervisors in the resolution/identification of
issues. Escalate critical issues to P&I and QA
management
• Coordinates and/or approves changes to
SOPs, specifications and Batch Records
(BRs),
• Initiate ERs/QARs, and Change Management as required.
• Coordinates shift personnel activities – i.e., training,
vacations, sick time, etc. to ensure there is
appropriate coverage in the QA department at all
times.
• Handles personnel issues with as they arise
• Ensure QA Inspectors curriculum and training are
up to date.
• Maintains quality assurance objectives complementary
to departmental and corporate
and procedures
• Maintains a working knowledge of government and
industrial quality assurance codes and standards.
• Knowledgeable in understanding PQS, cGMP’s,
Combination Product regulations and ANSI sampling
plans
• Reviews and approves Packaging Batch Records
• Understands and recognizes product status such as:
Approved Hold, Rejected, etc.

Basic Qualifications
Bachelor's degree or Associate's degree in technical or
science discipline and two years' experience and/or
training; or equivalent combination of education and
experience. Supervisory experience in a
pharmaceutical/combination product/medical devices
manufacturing industry preferable.

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