Supervisor, QC Chemistry

The Quality Control Chemistry Supervisor, under general supervision, will be responsible for planning, organizing, directing, and evaluating routine activities of the QC Chemistry staff as well as coordinating the installation and qualification of new analytical equipment in support of GMP release and stability testing.  The Chemistry Supervisor will lead tech transfer activities of qualified analytical methods from a designated donor laboratory.  The Chemistry Supervisor will play a pivotal role in selecting qualified personnel to staff the QC chemistry laboratory.   

External US

Essential Functions:

• Supervise and lead the QC Chemistry Staff, including hiring, supervision, coaching, mentoring, discipline, and performing annual review assessments.
• Coordinate and QC analytical testing for GMP release and stability testing.
• Ensure QC equipment is maintained in a qualified state.
• Prepare and execute tech transfer, qualification and validation protocols and reports as needed.
• Write, revise, and review Standard Operating Procedures (SOPs) and other Good Manufacturing Practices (GMP) documentation.
• Establish a system for managing test samples, reagents and reference standards.
• Review and approve data / reports during release & stability testing.
• Ensures laboratory compliance to established specifications and procedures.
• Reports excursion/out of specifications results and conducts investigations as needed.
• Assure the implementation of appropriate and timely corrective actions.
• Work closely with Quality Assurance and other departments to continuously improve the effectiveness of the Quality Management team.
• Work collaboratively with manufacturing and product development teams to improve quality, increase efficiency, solve problems, generate cost savings, and provide new product support.
• Interface with current and potential clients as well as interface with investigators during internal and external inspections.
• Follow all established laboratory, regulatory, safety, and environmental procedures.
• Identify deviations and report possible preventative and corrective actions.
• Perform other duties as assigned.

 

Required Skills & Abilities:

• Sound understanding and knowledge of SEC, UPLC, and Capillary Electrophoresis instrumentation and methodologies.
• Operate as a team leader, coordinate staff scheduling.
• Ability to follow safety procedures outlined in the Chemical Hygiene Plan.
• Utilize MSDS sheets to properly assess chemical hazards, spill response procedures, and PPE requirements if indicated.
• Develop staff to maximize contributions to team and company.
• Ability to multi-task and prioritize work assignments with little supervision.
• Excellent attention to detail.
• Computer proficiency required.
• Ability to accurately review and complete required documentation.
• Excellent written and oral communication skills.
• Excellent organization and analytical skills.

 

Working Conditions & Physical Requirements:

The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job.  Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.  While performing the duties of this job, the employee is regularly required to:

• Experience prolonged standing, some bending, stooping, and stretching.
• Use hand-eye coordination and manual dexterity sufficient to operate a keyboard, photocopier, telephone, calculator, and other office equipment is required.
• Ability to sit for long periods to work on a computer.
• Potential for exposure to hazardous chemicals, gases, fumes, odors, mists, and dusts, and other hazardous materials.
• Ability to wear personal protective equipment including safety glasses, lab coat, and gloves.
• Attendance is mandatory.

 

Minimum Qualifications:

• Master's degree preferably in Chemistry or Biochemistry with at least four (4) years' industry experience in a GMP / GxP or a comparable federally regulated environment of which two (2) years are in a lead or supervisory role; OR    
• Bachelor's degree preferably in Chemistry or Biochemistry with at least six (6) years' industry experience in a GMP / GxP or a comparable federally regulated environment of which two (2) years are in a lead or supervisory role.

Preferred Qualifications:

• Analytical laboratory experience in a GLP/GMP regulated environment is preferred.
• Experience in Trackwise Deviation Management software.
• Experience in Empower 3 software.