QC Supervisor - Raw Materials Chemistry
Actalent · St Louis, MO · 2 mo ago
On-siteQuality Assurance$42–$48.55/hrContract
This role manages the Raw Materials laboratory and a team of seven lab analysts, ensuring accurate, compliant, and timely testing of all incoming raw materials used in GMP manufacturing.
Responsibilities
- Lead and manage the Raw Materials laboratory and a team of seven lab analysts, providing clear direction, coaching, and support.
- Organize, schedule, and oversee testing of all incoming raw materials used in GMP manufacturing to ensure timely completion.
- Ensure successful performance of raw material testing by monitoring workflow, prioritizing tasks, and aligning resources with testing demands.
- Identify and remove obstacles that could delay completion of testing or assigned projects, ensuring on-time delivery of results.
- Review testing documentation for accuracy, completeness, and compliance with Good Documentation Practices (GDP).
- Review and revise raw material specifications, standard operating procedures (SOPs), and related documentation to maintain compliance and continuous improvement.
- Train new hires on department processes, procedures, tools, and laboratory techniques to ensure consistent and compliant testing practices.
- Lead investigations into deviations, nonconformances, or out-of-specification results related to raw material testing, and drive appropriate corrective and preventive actions.
- Interact with auditors and clients during visits and tours, representing the laboratory and explaining processes, controls, and quality systems.
- Oversee daily activities of the group to ensure adherence to quality standards, testing priorities, and maintenance of schedules.
- Perform performance management for direct reports, including setting expectations, providing feedback, and supporting career development.
- Review and approve documentation generated by the team, including test results, reports, and related records.
- Drive organizational change within the team by developing and empowering staff, building effective and diverse teams, and fostering a culture of engagement and accountability.
- Promote innovation, collaboration, transparency, and team effectiveness within the Raw Materials lab.
- Manage timelines and coordinate work schedules for employees to align with testing needs and project deadlines.
- Conduct or oversee verifications and qualifications for new testing methods and new client requirements related to raw materials.
- Perform other job duties as assigned to support the broader quality control and manufacturing operations.
Requirements
- Bachelor’s degree in biological science, chemistry, or a related field is required.
- Minimum of three years of experience leading people, such as in a team lead or supervisory capacity.
- Minimum of three years of experience in raw materials testing or similar experience in the pharmaceutical industry, with a total of at least five years of relevant laboratory experience.
- Experience with USP compendial raw material testing, including wet chemistry and titrations.
- Hands-on experience performing wet chemistry testing and colorimetric titrations.
- Experience with EP, JP, and USP testing for raw materials.
- Pharmaceutical and GMP experience, including work in a cGMP environment.
- Knowledge of GMP regulations and their application in a cGMP manufacturing setting.
- Knowledge of raw materials sampling techniques and sampling plans.
- Ability to drive functional, technical, and operational excellence within a laboratory environment.
- Ability to manage timelines and coordinate work schedules for laboratory staff.
- Strong ability to review and interpret laboratory data and documentation for accuracy and compliance.
- Demonstrated leadership skills in developing and empowering staff, building effective teams, and driving engagement.
- Strong communication skills to interact effectively with auditors, clients, and internal stakeholders.
Qualifications
- At least 3 years of prior supervisory or lead experience is preferred.
- Experience with analytical techniques such as HPLC is beneficial, with a preference for candidates who have raw materials USP testing experience.
- Ability to inspire and foster innovation, collaboration, transparency, and team effectiveness.
- Experience leading investigations into deviations and implementing corrective and preventive actions.
- Ability to support staff in meeting their personal career goals while aligning with organizational objectives.
- Strong organizational and problem-solving skills to identify and overcome obstacles to timely testing.
- Experience participating in or supporting audits and client visits.
Pay
The pay range for this position is $42.00 - $48.55/hr.
Benefits
- Medical, dental & vision
- Critical Illness, Accident, and Hospital insurance
- 401(k) Retirement Plan – Pre-tax and Roth post-tax contributions available
- Life Insurance (Voluntary Life & AD&D for the employee and dependents)
- Short and long-term disability
- Health Spending Account (HSA)
- Transportation benefits
- Employee Assistance Program
- Time Off/Leave (PTO, Vacation or Sick Leave)
Schedule
This is a Contract to Hire, fully onsite position based in Saint Louis, MO.