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
RESPONSIBILITIESPrimary responsibilities of this role include the following:
Safety Participate in weekly/monthly safety training, identify potential safety hazards, implement appropriate safety improvements and take part with investigations of safety related incidents Perform job functions in a safe manner consistent with site safe practices and regulatory (e.g. -OSHA) requirements Compliance Conduct assigned tasks in compliance with cGXP requirements, current industry standards, compendial standards, FDA expectations and internal proceduresEnsure investigations are conducted in a timely manner and are completed within established target completion dates Ensure that the Quality Control staff have been appropriately trained before performing a GMP task Productivity Serve as primary resource for planning and scheduling of tests Assist analysts as needed and troubleshoot if required Witness analytical notebooks of peersConduct testing consistent with established methods/proceduresSchedule and/or perform necessary validation, qualification and calibration of laboratory equipment/instrumentsSchedule method development, qualification, verification or validation according to established SOPs as well as FDA/USP/ICH guidelinesCustodian of laboratory systems and is proactive in implementing significant system improvements and / or laboratory proceduresCommunicate with clients, contractors, and regulatory agents as requiredProvide leadership and guidance to laboratory system owners and removes barriers to enable positive changeFunction as the laboratory representative on multi-department project teams Familiar with department and plant systems and effectively operates within systems to achieve desired resultsServe as backup to the Manager, Quality Control Staff Development / Training Identify areas of improvement in laboratory testingProvide technical training to analysts Leadership Lead by example, demonstrate through example the expected professional conduct, display integrity and honesty, inspire staff to excel and foster an environment of continuous improvementAssist management with supervising project task as neededQUALIFICATIONS
BS in Chemistry, Biochemistry, Biology or Microbiology or related discipline5+ 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 Thorough understanding of cGMP requirements Strong communication, interpersonal, and organizational skillsAbility to work with a sense of urgency in a fast-paced environment Strong technical writing and investigational skillsGMP DECISION-MAKING AUTHORITY The Team Leader Quality Control is responsible for decisions related to:
When an investigation is warrantedWhen analyst training is warrantedDisposition of laboratory test results and samples/batchesPrioritization of staff work assignments and testing schedulesSuitability of analytical equipment/instruments for useWhen a Change Control is warrantedWhen an analyst is qualified to perform testingApplies advanced theoretical knowledge, education, experience, and training in conjunction with technical resources to troubleshoot and resolve problemsThis role will offer a base salary that is commensurate with experience and demonstrated skills in the $70,000-$80,000.00 range. An Equal Opportunity Employer, including disability/vets.