Quality Control Manager (Union, MO)
Pharma Tech Industries is a leading contract manufacturer to the world's most trusted health and wellness brands. Pharma Tech Industries is seeking to hire a Quality Control Manager for the Union, MO facility.
Oversee the daily operations of a group of laboratory analysts and technicians. Sets clear objectives, and ensures that all activities within the lab are performed in compliance with cGMP. Be accountable for the accuracy, integrity, and quality of all results generated by the QA laboratory. This position reports directly to the Director Quality Assurance.
Job Description and Responsibilities:
- Manage day to day work activities and testing priorities to ensure production and customer demands are met.
- Supervise and/or conduct laboratory investigations.
- Work closely with the Engineering and Technology Transfer groups in a team environment to effect transfer of new products and processes to PTI sites. Provide technical support for test method transfers and test method validations (generation and execution).
- Ensure direct reports are adequately trained to perform job assignments.
- Participate in personnel decisions (interviewing, hiring, performance appraisals, promotion, disciplinary action, staff development, coaching and counseling) regarding subordinate staff.
- Write, revise or review SOP’s, analytical protocols, analysis reports, specifications, and controlled forms as required.
- Serve as subject matter expert on the Laboratory Systems during inspections.
- Manage internal and external labs OOS investigations, as necessary.
- Monitor USP monographs and external customer specifications for changes/updates and update laboratory procedures suitably.
- Manage relationships with contract laboratories to ensure testing times are met.
- Manage specification issues/concerns with customers.
- Generate/execute laboratory instrumentation IQ/OQ/PQ.
- Mentor and develop direct reports.
- Perform other duties as assigned or as business needs require.
- This job may require travel to other PTI sites, customer sites, contract manufacturers and suppliers. Approximately 15% domestic travel may be required.
Education and Experience:
- Minimum of a BS degree in a Science or Engineering discipline, or relevant experience; about 8 years of relevant industry experience, including about 3 years of management/supervisory experience required.
- Must have thorough understanding of cGMP requirements as they relate to regulatory compliance, technology transfer, and validation of process, equipment, cleaning and computer systems.
- Hands on experience in regulatory inspections.
- Must possess the understanding of scientific methods and the ability to interpret and communicate data to management, customers and regulatory agencies as required.
- Experience with method development and validation is a plus.
- Appreciates the organizational vision/ site strategy and understands how the department and team related objectives are aligned.
- Ability to thrive in a small company environment with sharp cost control focus and a strong sense of urgency.
- Cross functional communicator and process facilitator.
- Ability to be diplomatic, assertive, and skilled in conflict resolution.
- Possesses exceptional inter-personal, communication and writing skills.
- Creative, flexible, and innovative team player.
- Ability to work in a fast paced, constantly changing work environment.
- Ability to interact with all levels within the organization and with client contacts.
The above information on this description has been designed to indicate the general functions and level of work performed by employees within this classification. It is not designed to contain or be interpreted as a comprehensive inventory of all duties, responsibilities, and qualifications required of any employee assigned to this job. There will be other tasks and assignments as required to ensure maximum flexibility.