Quality Control Manager


Gaithersburg, MD


Our client, a biotechnology organization is hiring a Quality Control Manager. The Quality Control Manager will oversee Raw Materials and be responsible for managing, monitoring and reporting Quality Control Raw Material(RM) schedules and results to ensure the department fully supports cGMP validation, clinical and commercial activities and programs, while also providing leadership and oversight of the Quality Control raw materials personnel. This individual will interact extensively with QC management and analytical personnel, other departments, and business partners in order to gather, analyze, disseminate and report necessary data and information.

Responsibilities and Job Duties

  • Manages the day to day work of personnel that contribute to the Quality Control department’s raw materials (RMs) functions, ensuring all work is completed properly and in a timely manner and in compliance with all GMP regulations and that all testing of raw materials is compliant with current compendia (USP/NF, EP, JP, ACS, and FCC as needed).
  • Communicates requirements and expectations of the employee’s daily job; performs all aspects of a supervisor’s role including hiring, training, coaching, developing, providing regular feedback to employee about his/her performance, and managing performance or behavioral deficiencies
  • Manages and reviews factors which affect Quality Control RM schedules, relevant equipment calibration and preventive maintenance, personnel training, etc., and tracks RM receipts, shipments and inventories, assuring that relevant deliverables (RMs, samples, forms, risk assessments, reports, specifications, etc.) are provided on time to support corporate, CMC, and departmental goals
  • Inspects, samples and tests incoming RMs; performs inspections, sampling and testing according to internal specifications, procedures (SOPs), drawings and other applicable controlled documents ensuring that RMs are released per schedule and within an established turn-around time
  • Develops RM specifications, testing plans, risk assessments and SOPs, as needed, for manufacturing of products and/or affected by compendia changes and/or changes arising from quality events
  • Manages contract testing organization (CTO) communications including shipping, receiving, testing progress, and results analysis for raw material samples; collaborates with Materials Management to prepare shipments of raw material samples for testing performed by CTOs; ensures that the CTOs are adhering to timelines and budgets as outlined in contracts; assists in planning/scheduling activities in alignment with manufacturing and CTOs
  • Assists in designing and making recommendations for continuously improving Quality Control systems and processes to improve efficiencies and effectiveness
  • Performs compendial reviews (USP, Ph.Eur., BP, JP, ChP) for new and/or revised compendial requirements that apply to RMs, and revises specifications accordingly
  • Records data in LIMS and SAP, ensuring completeness and accuracy per cGMP; compiles and reviews data per cGMP; ensures data storage and archiving are performed per established procedures. Reviews and approves data entered by QC Analysts via LIMS to ensure accuracy and completeness, and serves as a LIMS subject matter expert . Also assists with developing, establishing, validating and maintaining LIMS
  • Oversees lab equipment calibration and maintenance processes as required for testing per standard operating procedures; ensures that instruments and equipment used in inspection, sampling and testing are kept in a qualified and calibrated state. Participates in troubleshooting of raw material and analytical test methods and instruments, as needed
  • Ensures the sampling rooms are maintained at a constant state of compliance and inspection readiness at all times and coordinates with appropriate departments when there are issues/concerns
  • Reports discrepancies and nonconforming materials to management and supports subsequent investigations; initiates and monitors progress of raw material and/or analytical related Quality event records (e.g., deviations and CAPAs) and conducts investigations to determine root cause and possible resolution. Also identifies and responds to out of trend RM results, and participates in out of trend and out of specification investigations
  • Provides technical guidance as needed to CTOs to address and investigate invalid events and/or discrepancies. May perform internal/external audits of CTO QC laboratories and relevant testing and sampling processes to ensure compliance to regulations and standards
  • Performs special projects related to problems encountered with analytical testing and instruments, and makes recommendations for solutions that will minimize future issues
  • Provides back up support to QC Analysts if needed, including raw material sampling, testing, data entry, shipping, etc.
  • May perform other duties as assigned


Education, Experience, & Credentials

  • High School diploma and minimum of 9 years of quality control experience; or
  • Associate’s degree and a minimum of 7 years of quality control experience; or
  • Bachelor’s degree and a minimum of 5 years of quality control experience
  • Minimum of 2 years of supervisory experience focused on managing performance and productivity and developing team members
  • Significant knowledge of and experience with standard concepts, practices and procedures within Quality Control and working in a GMP or GLP testing environment
  • Prior experience in one or more of the following areas required: Quality Control, RMs testing, and/or GMP testing

Knowledge, Skills and Abilities

  • Understands and applies compendial requirements
  • Works on extremely complex problems in which analysis of situation or data requires an in‑depth evaluation of intangible variables
  • Possesses working knowledge of LIMS and GMPs and/or GLPs
  • Acts independently to determine schedules, methods and procedures on new assignments
  • Demonstrates the confidence to exercise independent judgment in developing methods, techniques, and evaluation criteria for obtaining results
  • Possesses ability to organize and prioritize daily activities and projects, and handle multiple priorities to meet customers’ needs in a fast-paced environment
  • Possesses excellent written and verbal communications skills
  • Demonstrates ability to manage conflict and bring resolutions to technical problems and human interaction issues that arise
  • Proficient in the use of Microsoft or equivalent software; word processing, email, spreadsheet or other analysis tools, database, and Internet
  • Able to stand for periods of time when performing tasks on the floor
  • Able to work a varied schedule including off shift and weekends
  • Able to lift up to 50 pounds

Supervisory Responsibilities

Will supervise the activities of 1-2 lower-level personnel

Preferred Qualifications

  • Degree in a science related field
  • Experience in a Pharmaceutical company
  • Experience implementing, validating, utilizing and maintaining LIMS (particularly LabVantage)
  • Experience with process efficiencies (5S, lean and Six Sigma, etc.)
  • Relevant Project Management Institute (PMI) certification

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