Supervisor, Quality Assurance

2 weeks ago

Maryland Heights, MO, United States Kindeva Drug Delivery Full time
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.

#LI-onsite #LI-BM1

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