QC Manager
Pharmaceutical Manufacturing
MO

Global pharmaceutical manufacturing site is seeking a QC Manager for aseptic pharmaceutical manufacturing site near St. Louis MO. The QC Manager would be managing a large quality group (120 people), the process that develops, establishes and maintains quality assurance programs, policies, processes, procedures, and controls ensuring that the performance and quality of products confirms to established standards.

Responsibilities would include:
Manage Quality Control Analytical, Method Validation, Raw Materials and LIMS.
Supervise departmental personnel directly and through subordinate managers and/or supervisors.
Ensure all necessary testing is carried out.
Approve specifications, sampling instructions, test methods and other QC procedures.
Approve and monitor any contract analysts.
Ensure the maintenance of their department, premises and equipment.
Ensure the appropriate validations are done.
Ensure the required initial and continuing training of their department personnel is carried out and adapted according to need.
Ensure the laboratory records are evaluated and signed by an authorized person before they are sent to the Quality Department.

MINIMUM REQUIREMENTS:
Bachelors degree in chemistry, engineering or biology. Masters degree in a technical discipline preferred.
Five or more years of management experience and five or more years of bench lab and QC/QA experience. Experience in a pharmaceutical manufacturing environment.
STRONG LEADERSHIP SKILLS- MANAGES A GROUP OF 120 PEOPLE, 3 labs and 3 supervisors
Experience in aseptic manufacturing
Understanding laboratory capacity studies.
Effective interpersonal skills as well as written/verbal communication skills.
Expertise in the manufacture and control of sterile products, analytical analysis techniques and statistical quality control.
Good working knowledge of FDA requirements and USP testing guidelines. Background should include analytical method validation work.
Should have a thorough understanding of Quality systems. Ability to use relevant software packages to process and analyze data.

Candidates should submit resumes in WORD.

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