SUMMARY OF POSITION

The Team Leader Quality Control:

• Leads and manages activities supporting the laboratory function in executing daily operations and testing necessary to support commercial products.
• Anticipates and resolves problems independently while conforming to SOPs and GMP regulations
• Monitors the scientific and financial progress of projects that they are assigned
• May have responsibility for a laboratory group or function and may have direct reports

ORGANIZATION STRUCTURE

The Team Leader Quality Control reports to the Manager Quality Control or Director QC.

Any of the following Quality Control staff may report to the Team Leader Quality Control:

• Chemist-analyst 1, 2, and 3
• Microbiologist 1, 2, and 3
• Metrologists

RESPONSIBILITIES

Primary responsibilities of this role include the following:

1. Safety
   1. Participate in weekly/monthly safety training, identify potential safety hazards, implement appropriate safety improvements and take part with investigations of safety related incidents
   2. Perform job functions in a safe manner consistent with site safe practices and regulatory (e.g. -OSHA) requirements
2. Compliance
   1. Conduct assigned tasks in compliance with cGXP requirements, current industry standards, compendial standards, FDA expectations and internal procedures
   2. Ensure investigations are conducted in a timely manner and are completed within established target completion dates
   3. Ensure that the Quality Control staff have been appropriately trained before performing a GMP task
3. Productivity
   1. Serve as primary resource for planning and scheduling of tests
   2. Assist analysts as needed and troubleshoot if required
   3. Witness analytical notebooks of peers
   4. Conduct testing consistent with established methods/procedures
   5. Schedule and/or perform necessary validation, qualification and calibration of laboratory equipment/instruments
   6. Schedule method development, qualification, verification or validation according to established SOPs as well as FDA/USP/ICH guidelines
   7. Custodian of laboratory systems and is proactive in implementing significant system improvements and / or laboratory procedures
   8. Communicate with clients, contractors, and regulatory agents as required
   9. Provide leadership and guidance to laboratory system owners and removes barriers to enable positive change
   10. Function as the laboratory representative on multi-department project teams
   11. Familiar with department and plant systems and effectively operates within systems to achieve desired results
   12. Serve as backup to the Manager, Quality Control

1. Staff Development / Training
   1. Identify areas of improvement in laboratory testing
   2. Provide technical training to analysts

1. Leadership
   1. Lead by example, demonstrate through example the expected professional conduct, display integrity and honesty, inspire staff to excel and foster an environment of continuous improvement
   2. Assist management with supervising project task as needed

QUALIFICATIONS

1. BS in Chemistry, Biochemistry, Biology or Microbiology or related discipline
2. 5+ years experience in a laboratory environment (quality control or similar pharmaceutical industry experience preferred), or MS in Chemistry, Biochemistry, Biology or Microbiology or related discipline and 3+ years experience
3. Thorough understanding of cGMP requirements
4. Strong communication, interpersonal, and organizational skills
5. Ability to work with a sense of urgency in a fast-paced environment
6. Strong technical writing and investigational skills

GMP DECISION-MAKING AUTHORITY

The Team Leader Quality Control is responsible for decisions related to:

1. When an investigation is warranted
2. When analyst training is warranted
3. Disposition of laboratory test results and samples/batches
4. Prioritization of staff work assignments and testing schedules
5. Suitability of analytical equipment/instruments for use
6. When a Change Control is warranted
7. When an analyst is qualified to perform testing
8. Applies advanced theoretical knowledge, education, experience, and training in conjunction with technical resources to troubleshoot and resolve problems

This role will offer a base salary that is commensurate with experience and demonstrated skills in the $70,000-$75,000 range

"An Equal Opportunity Employer, including disability/vets."