Quality Control Lab Manager

2 weeks ago

Reston, Virginia, United States Accupac Full time
Job Summary

The Manager, Lab Services-Analytical position at Accupac is responsible for overseeing the daily operations of the Laboratory Services department. This includes training, evaluating, and directing laboratory staff, reviewing and implementing customer test methods, and investigating and resolving technical issues related to laboratory services.

Key Responsibilities
  • Prioritize testing schedules to meet the needs of manufacturing, production, and customer service departments.
  • Ensure final data completion, review, and proper documentation to comply with company policies, SOPs, cGMP, GDP, and relevant industry and regulatory requirements.
  • Develop contingency plans to support production needs and maintain effective communication between the lab and other departments.
  • Provide guidance on troubleshooting issues related to instruments, test methods, lab chemicals, standards, and samples.
  • Maintain knowledge of customer specifications and testing procedures.
  • Ensure all raw materials, bulks, and finished goods are tested in accordance with customer specifications and priority basis.
  • Investigate and document test failures and take corrective action in accordance with regulatory guidelines.
  • Evaluate the lifecycle of laboratory instruments and ensure IQ/OQ and PQ of laboratory instrumentation.
  • Ensure data integrity of laboratory data and establish department KPIs and metrics.
  • Assess new test methodology and requirements for new product launches and resolve test method issues with customer technical staff.
  • Provide technical support and evaluate time and cost aspects of laboratory work associated with new product launches.
  • Assist in investigations of operational problems and provide supporting data.
  • Coordinate outside lab testing to support releases and develop and implement continuous improvement plans for laboratory productivity, cost control, and output.
  • Review and approve SOPs, specifications, and other documentation required to administer the laboratory.
  • Participate in customer audits and regulatory audits as a subject matter expert.
Requirements
  • Experience in pharmaceutical product testing and quality control.
  • Knowledge and experience with Total Quality Management Systems, Statistical Process Control, and other quality management philosophies.
  • Thorough understanding of compendial testing methodology, analytical chemistry, and chemical instrumentation, particularly HPLC and GC.
  • Effective interpersonal, leadership, and organizational skills.
  • Fluency in written and spoken English.
  • Ability to use computers for word processing and data analysis.
  • Ability to manage multiple tasks and issues simultaneously and prioritize, delegate, and take personal action in a fast-paced environment.
  • Understanding of laboratory safety requirements and the MSDS system.
  • Understanding of LIMS, TrackWise, and ELN systems.
  • Ability to read, comprehend, and interpret technical data.
  • Ability to represent Accupac to customers and regulatory agencies.
Physical Requirements
  • Sitting for a significant portion of the workday.
  • Walking/standing up to six hours each workday.
  • Hearing and executing clear speech, in person and over the telephone.
  • Lifting/carrying items up to 40 pounds.
  • Hearing phones ring, alarms sound through ambient noise and everyday conversation.
  • Possessing good color vision.
Supervisory Responsibilities
  • Analytical Laboratory Supervisors, Shift Leads, and Analytical Chemists.
Travel
  • Minimal.
Education and/or Experience
  • Bachelor's Degree in Analytical Chemistry or Chemistry from a four-year college is required.
  • MS degree in Analytical Chemistry is preferred.
  • Minimum of five years management experience in the pharmaceutical industry is a must.

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