QC Chem Supervisor

Location: Buena, NJ

Essential Responsibilities:

  • Responsible for the testing coordination and technical support of testing within the Quality Control laboratory for upcoming requirements based on the production and compliance schedules.
  • Ensure completion of all testing, including protocol/validation testing, in a timely and appropriate manner.
  • Responsible for troubleshooting physical and analytical testing issues that arise. Provide suggestions and problem resolution based on technical expertise.
  • Ensure compliance with testing SOPs and specifications while assisting in the implementation of quality and regulatory requirements (i.e. FDA, GLP, cGMP, and USP guidelines).
  • Provide leadership for quality operations, to implement clear policies, processes, and metrics in line with business strategy and regulatory requirements that drive consistency and compliance with quality standards.
  • Responsible for initiating investigations and driving them to completion ensuring appropriate root cause is determined for all out-of-specification and out-of-trend events within thirty (30) days.
  • Responsible for the approval of results in LIMS prior to being submitted to Quality Assurance for release.
  • Responsible for reviewing/approving new monographs and registrations in LIMS.
  • Responsible for reviewing/approving new or updated specifications.
  • Write and revise routine laboratory SOPs as needed to ensure processes are accurate and meeting cGMP requirements.
  • Review, approve, and train on new and revised quality documents (specifications, analytical test methods, SOPs, protocols, technical documents, etc.) in support of product testing and continued improvement to the Quality System.
  • Provide leadership for quality operations, to implement clear policies, processes, and metrics in line with business strategy and regulatory requirements that drive consistency and compliance with quality standards.
  • Responsible for maintaining compliance to GMPs in all areas.
  • Assist in the compilation of documents for ANDA submissions.
  • Train and mentor junior staff while also providing guidance on the resolution of complex issues.
  • Develop a highly engaged, self-empowered and capable team through goal setting, mentoring, talent development activities, and reviews.
  • Adhere to safety and housekeeping requirements.
  • Keep upper management informed of all key quality findings and issues.
  • Assume other activities and responsibilities from time to time as needed/directed.

Qualifications:

  • Bachelor’s degree in Chemistry or other physical sciences
  • Minimum 3-5 years of pharmaceutical industry or laboratory experience required
  • Minimum 1-3 years of previous supervisory experience preferred
  • Must possess excellent supervisory and interpersonal skills with the ability to communicate with direct reports, peers and managers.
  • Strong foundation in analytical chemistry and quantitative analysis
  • Ability to operate and troubleshoot procedures for laboratory equipment
  • 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.
  • Collaborative working style. Demonstrates professionalism, cooperation and willingness to support team and company priorities in a fast-paced laboratory setting.
  • Demonstrated ability to work on multiple projects and meet timelines.
  • Well-developed interpersonal skills.  Ability to get along with diverse personalities.
  • Good written and oral communication skills.

Physical Demands/Factors:

The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job.

  • While performing the duties of this job, the employee is regularly required to talk or hear.
  • The employee frequently is required to stand; walk; use hands to handle or feel; and reach with hands and arms.
  • The employee is occasionally required to sit; climb or balance; and stoop, kneel, crouch or crawl.
  • Specific vision abilities required by this job include close vision, distance vision, color vision, peripheral vision, depth perception and ability to adjust focus.
  • The employee must be able to wear all required PPE, including safety glasses, ear plugs, and safety shoes.

Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

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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