Laboratory Operations Group Lead

Location: Buena, NJ

Job Summary:

Responsible for maintaining laboratory operations, raw material sampling, sample coordination of raw materials, packaging components, bulk, finished product and stability samples.

Reporting Relationships: 4-6 direct reports

Essential Responsibilities:

  • Responsible for supervising both sterile and topical sampling areas to ensure compliance with approved SOP’s.
  • Responsible for FDA and CFR raw material sample retains as well as Finished Product retains.
  • Responsible for reviewing and approving all Raw Material Sampling Cards.
  • Responsible for approving external testing lab allocations as well as the review of all external testing results.
  • Responsible for the chain of custody of samples which includes raw materials, packaging, bulk, finished product, commercial stability and pre-approval stability.
  • Responsible for overseeing, reviewing and approving all minimum fill and weight loss testing.
  • Responsible for ordering all laboratory supplies. For example, glassware, reagents, reference standards, chromatographic columns, disposable testing supplies, PPE, notebooks, etc.
  • Ensure compliance to good documentation practices within group.
  • Responsible for hazardous and non-hazardous waste management within the quality control laboratory.
  • Responsible for good housekeeping and glassware washing within the quality control laboratory.
  • Work with manufacturing, packaging, CMOs, and quality assurance to manage receipt of laboratory samples.
  • Oversight of sample distribution to respective testing departments.
  • Write and revise routine laboratory SOPs as needed.
  • Responsible for maintaining compliance to GMPs in all areas.
  • Assist QC department members with tasks as needed, this may include input for the raw materials testing lab as well as the stability program.
  • Keep Manager informed of all key quality findings and issues.
  • Assume other activities and responsibilities from time to time as needed/directed.

Qualifications:

  • BS degree in a science related field and a minimum of 5 years of experience in Quality Control.
  • Demonstrated ability to work on multiple projects and meet timelines
  • Knowledge of cGMP requirements. Practical experience with document control, and QA support of manufacturing
  • Strong knowledge of Microsoft Word and Acrobat (PDF) documentation systems.
  • Excellent organizational skills.
  • Demonstrated ability to work on multiple projects and meet timelines.  Detail oriented
  • Collaborative working style. Demonstrates professionalism, cooperation and willingness to support team and company priorities in a fast-paced laboratory setting.
  • Well-developed interpersonal skills.  Ability to get along with diverse personalities.
  • Good written and oral communication skills.

Physical Demands/Factors:

  • Physical Demands
    • Mobile/Ambulatory
    • Ability to lift
    • Sight
  • Environmental
    • Inside and outside work
    • Move between buildings
    • Temperature variations
    • Sit and stand for long periods

 

This job description is not all-inclusive. It acts as a guideline and is subject to change over time. Additional duties may be assigned based on business needs

 

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