Quality Control Lab Manager

4 weeks ago

Lakewood, New Jersey, United States Accupac Full time
Job Description

The Quality Control Lab Manager position at Accupac is responsible for overseeing the daily operations of the Laboratory Services. This includes managing laboratory staff, reviewing and implementing customer test methods, and investigating technical issues related to laboratory services.

The Manager prioritizes testing schedules to meet the needs of manufacturing, production, and customer service departments. They also participate in quality-related activities outside of the laboratory and serve as the primary point of contact between the laboratory and other departments.

Key Responsibilities:

  • Assure testing priorities support OPS and customer service schedules.
  • Ensure final data completion, review, and proper documentation comply with company policies, SOPs, cGMP, GDP, and relevant industry and regulatory requirements.
  • Develop contingency plans to support production needs.
  • Assure adequate communication of priorities exists between the lab and other departments and within the lab from shift to shift.
  • Provide guidance on troubleshooting issues regarding instruments, test methods, lab chemicals, standards, and samples.
  • Maintain knowledge of customer specifications and testing procedures.
  • Assure 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.
  • Ensure IQ/OQ and PQ of laboratory instrumentation.
  • Ensure data integrity of laboratory data.
  • Establish department KPIs and metrics.
  • Assess new test methodologies and requirements for new product launches.
  • Resolve test method issues involving interaction with customer technical staff. Respond to technical questions from customers about laboratory issues.
  • Evaluate time and cost aspects of laboratory work associated with new product launches and provide technical support.
  • Assist in investigations of OPS by providing supporting data.
  • Coordinate outside lab testing to support releases.
  • 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 as a subject matter expert in customer audits and regulatory audits.

Requirements:

  • Experience in pharmaceutical product testing/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 diverse tasks and issues simultaneously, through prioritization, delegation, and personal effort in a fast-paced, high-volume 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/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 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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