Director Quality Control
Job CategoryProf-Operations Management
Job TitleDirector Quality Control
Employment TypeDirect Placement
Director, Quality Control
The Director, Quality Control (QC) follows established quality control/quality assurance procedures to ensure the correct and prompt test of raw materials, mixtures and finished products. The Director, Quality Control oversees all activities in the Quality Control laboratories.
- Plan, direct and coordinate the operational activities of the Quality Control lab.
- Identify, develop, direct, review, and approve analytical methods, validation protocols, and laboratory equipment to be performed in-house.
- Meet company expectations for timeliness of lab studies and product shipments.
- Ensure test methods and production processes meet specified protocol or SOP requirements, are scientifically sound and are performed error-free.
- Ensure quality systems are being applied in the performance and documentation of lab studies and production processes.
- Assist the QC Laboratory Manager and Operations with the interpretation of test results and to determine additional steps to be taken, as needed.
- Perform an investigation identifying root cause and corrective/preventive action in the event of a failure.
- Ensure compliance with GMP, FDA, OSHA, and all other regulatory requirements, in accordance with company policy. Ensure compliance with applicable quality and regulatory requirements (qualified/trained staff, validated equipment, proper documentation practices, etc.).
- Demonstrate awareness of cross-contamination issues while testing materials, and exhibit vigilance in taking proper precautions to maintain a clean and sterile environment.
- Maintain a safe and healthy work environment by establishing and enforcing organizational safety standards and adhering to legal regulations.
- Take initiative and make sound decisions within the guidelines provided, and is willing, if necessary, to stop a procedure or process when SOP or product quality is in question.
- Address observations or recommendations as well as implement corrective/preventive actions as needed.
- Demonstrates knowledge of and teaches department procedures and company polices, pays attention to detail in all aspects of testing, ensuring the completion of all paperwork accurately, neatly and fully.
- Demonstrate initiative and job knowledge by suggesting ideas, discovering new and better ways of accomplishing goals and finds innovative, well thought-out solutions to problems.
- Ability to perform other duties as required.
- Build and lead a highly performing team, secure the best talent, develop and strengthen staff and future leaders, and provide ongoing coaching and feedback.
- Conduct formal and informal performance assessments of staff, including performance versus expectations and goals, behaviors and leadership potential, and seek the same for self.
- Promote the Company’s Mission and Values, including an accountable, innovative, and results-oriented culture that promotes customer service, openness, teamwork, mutual trust, and respect.
- Advanced Degree in Chemistry or related field
- 10+ years of experience in laboratory management; 5+ years in FDA regulated environment.
- Experience with ISO and/or GMP standards
- Health insurance coverage including, dental, vision
- Opportunity for advancement
- Competitive pay based on experience
All applicants must submit to background check and drug screening.
This position does not offer sponsorship
Equal Opportunity Employer
Minorities / Females / Protected Veterans / Individuals with Disabilities