Quality Control Supervisor

The Pharmaceutical Quality Control Supervisor is responsible for overseeing and managing the Quality Control (QC) department, ensuring adherence to stringent quality standards and regulatory compliance. This role involves leading a team of QC analysts, managing laboratory operations, and implementing strategies to maintain consistent compliance and product excellence.

Responsibilities

Team Leadership:

• Supervise and manage a team of QC analysts, assigning tasks, providing training, and evaluating performance. Collaborate with the Training department to maintain the skills matrix for all lab employees.
• Foster a positive and collaborative work environment, promoting teamwork and employee development.
• In charge of cross functional communication with manufacturing teams, supervisor and QA to ensure manufacturing and product testing requirements are met as needed on time, avoid emergencies.
• Provide leadership in quality programs and initiatives; make recommendations to continuously improve systems.

Quality Assurance:

• Conduct investigations (accidents/disciplinary's, root-cause analysis) and recommend and implement the appropriate corrective or preventative actions in a timely manner.
• Proficient with deviation and out of specification write up and investigation of root cause and CAPA.
• Strong knowledge on compliance of 21 CFR 210 & 211 and ICH Q7 and safety requirements. Ensure compliance with lab data integrity.
• Oversee the implementation and maintenance of quality control systems and procedures, ensuring compliance with cGMP and other regulatory requirements.
• Review and approve QC documentation, including test reports, protocols, and deviations.
• Conduct internal audits to identify and address quality issues and opportunities for improvement.

Laboratory Operations:

• Communicate monthly, weekly and daily schedules with QC Team and Management to ensure appropriate prioritization and alignment.
• Proficient in testing methods related to wet lab, HPLC, ICS system, titrators, FT-IR, UV and all other lab instruments.
• Manage laboratory resources, including equipment, reagents, and supplies, to ensure efficient operations.
• Coordinate with third party labs on current and new testing needs.
• Monitor and maintain laboratory equipment, ensuring calibration and validation are current.
• Implement and maintain quality control standards for laboratory operations, including sample management, data integrity, and document control.
• Support with designing, execution and summarizing analytical method validation/verification protocols and reports.

Product Testing:

• Complete hands-on training on Sentio's analytical testing requirements and build skills and confidence to support as a qualified trainer in the QC lab.
• Oversee the testing of raw materials, in-process materials, and finished products to ensure compliance with specifications and standards.
• Investigate and resolve quality issues and deviations, implementing corrective and preventive actions.
• Review and approve test results, ensuring accuracy and reliability.
• Gain knowledge and compliance requirements on microbiology testing.

Regulatory Compliance:

• Stay updated on current regulatory requirements and industry standards, ensuring compliance with FDA, ICH, and other relevant agencies and guidances.
• Participate in regulatory inspections and audits, providing necessary documentation and addressing any findings.
• Collaborate with other departments, including production, R&D, and regulatory affairs, to ensure seamless operations and compliance.

Continuous Improvement:

• Identify opportunities for process improvement and implement changes to enhance efficiency and quality.
• Participate in root cause analysis and problem-solving activities to address quality issues.
• Promote a culture of continuous improvement and innovation within the QC department.

Requirements:

Bachelor's degree in Chemistry, Biology, or a related scientific field.

• Minimum of 5 years of experience in pharmaceutical quality control, including supervisory experience.
• In-depth knowledge of cGMP regulations and quality control principles.
• Strong leadership and interpersonal skills.
• Excellent problem-solving and analytical skills.
• Proficiency in laboratory techniques and instrumentation.
• Strong attention to detail and accuracy.
• Knowledge of Aseptic techniques.
• Periodic flexibility in timings to cover business requirements.
• Ability to work well in a collaborative team environment

Job Type: Full-time

Pay: $65,000.00 - $75,000.00 per year

Benefits:

• 401(k)
• 401(k) matching
• Dental insurance
• Health insurance
• Health savings account
• Paid time off
• Vision insurance

Schedule:

• 8 hour shift
• Monday to Friday

Education:

• Bachelor's (Required)

Experience:

• Quality Control (cGMP Pharmaceutical Analysis): 2 years (Required)
• HPLC: 2 years (Required)

Ability to Commute:

• Maryland Heights, MO 63043 (Required)

Ability to Relocate:

• Maryland Heights, MO 63043: Relocate before starting work (Required)

Work Location: In person

Salary : $65,000 - $75,000