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Manager Quality Control

Category Quality Control City Maple Grove State Minnesota

The Manager Quality Control manages a team of supervisory staff, chemists, and supporting staff within the Quality Control organization. This includes performance reviews, coaching, resource allocation, and budget planning. Also, provides analytical and technical leadership to QC members to successfully address product or testing issues (e.g. laboratory investigations, method deviations, etc.).

Ensures the Quality Control team meets applicable testing timelines for release, stability, technical services, and development samples. Interfaces with key individuals in TS, CAS, QA, MM to resolve critical and complex technical or process issues. Collaborates cross-functionally and represents QC on project teams for new product launches or when changes are made to existing approved methods.

  • Manages Quality Control staff to meet departmental and corporate objectives.
  • Manages personnel development and behaviors to ensure a professional environment is maintained. Reviews performance and development areas with reports. Manages employee promotions and addresses performance issues promptly (including terminations) as required.
  • Effectively perform recruiting activities. Identifying, conducting interviews and hire new employees as required.
  • Review and revision of applicable job descriptions as needed.
  • Demonstrates cooperation and professionalism with all members of the Upsher- Smith organization. Maintains strong communication skills within the company by addressing issues properly. Displays strong critical thinking skills.
  • Functions as a subject matter expert for instrumentation, analytical testing techniques/procedures, and cGMP compliance as applicable.
  • Demonstrates a strong understanding of instrumentation and analytical testing. Provides troubleshooting recommendations for method issues.
  • Demonstrates a strong understanding of the USP and other pharmacopeias.
  • Demonstrates a strong understanding of the SAP computer system and other relevant laboratory software applications, including electronic laboratory notebook (Biovia). Provides troubleshooting and training for the applications that relate to Quality Control.
  • Provides oversight for scheduling the testing of raw materials, in-process materials, and finished goods. Interfaces with colleagues in Operations when cross-department scheduling conflicts arise.
  • Assists in developing, implementing, and monitoring appropriate procedures and controls (e.g. SOPs, analytical methods, and material specifications). Evaluates laboratory procedures to ensure cGMP compliance.
  • Performs final review of data and release of raw materials and finished goods as required.
  • Responsible for communicating issues and concerns about Quality Control operations to senior laboratory management.
  • Responsible for communicating atypical and out-of-specification results cross-functionally and to senior leadership. Ensures investigations of atypical and out-of-specification results or other product investigations are conducted appropriately.
  • Manages departmental communication with outside vendors/laboratories is appropriate. Ensures the coordination and review of the test results from outside testing laboratories is appropriate.
  • Demonstrates stong technical writing skills. Authors and reveiws various technical documents, including Annual Product Review reports, test methods, specifications, change control justifications, submission documents, method validation protocols and reports, and data summaries as necessary.
  • Monitors compendial changes. Collaborates with CAS to ensures testing procedures and specifiations are updated accordingly.
  • Ensures the approved budget is maintained. Approves expenditures as necessary.
  • Identify and champion the implementation of new initiatives within Quality Control including new instrumentation, training, and GMP processes to improve the efficiency and capabilities of the Quality Control processes and operation
  • Ensure all Quality Control personnel are prepared for FDA and customer audits. Aids in developing deficiency responses to the audits. Perform contract laboratory audits as necessary.
  • Demonstrated understanding of ICH guidelines and FDA guidances and uses that knowledge to collect required submission data and supporting information to support changes to QC testing requirements or QC processes.
  • Helps establish laboratory safety policies and standard operating procedures and ensures compliance with them.
  • Interact with FDA or customers as a QC representative during audits or meetings. Can clearly present and explain laboratory documents and procedures (e.g. specifications, laboratory investigation reports, and data packets) to an auditor independently.
  • Represents Quality Control on project teams and coordinates laboratory activities to meet project timelines.

Requirements:

  • A Bachelor Degree in Chemistry or related science field (with 12 credits of college chemistry) with a minimum of 12+ years of experience, preferably in the pharmaceutical industry, and a minimum of 6 years of supervisory experience.
  • A Master's degree in Chemistry or related science field (with 12 credits of college chemistry) and a minimum of 10+ years of experience, preferably in the pharmaceutical industry, and a minimum of 4 years of supervisory/leadership experience.
  • Demonstrates analytical chemistry knowledge.
  • Has experience working in a laboratory environment, preferably in the pharmaceutical industry.
  • Demonstrated verbal and written communication skills are a must.
  • Has the ability to work independently and within the framework of a team.
  • Can effectively multi-task.
  • Has a strong understanding of cGMP, USP and FDA guidances and procedures.
  • Has experience or training with SAP, Microsoft Word and Excel, and other relevant computer software.

Upsher-Smith Laboratories, LLC. is committed to providing equal employment opportunity to all applicants and employees according to all applicable equal opportunity and affirmative action laws, directives and regulations of federal, state and local governing bodies and agencies. In keeping with this commitment, Upsher-Smith Laboratories, LLC. will recruit, hire, train and promote persons in all job titles, without regard to race, color, creed, religion, sex (including factors related to pregnancy or child birth), national origin, age, marital status, familial status, disability, sexual orientation, gender identity status with regard to public assistance, employment status, local human rights commission activity, status as a protected veteran, genetic information, atypical hereditary cellular or blood trait, or any other protected category.
Job ID 8037

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