QA Associate / Quality Systems Coordinator

Location: Buena, NJ

Reporting Relationships:  Individual Contributor

Essential Responsibilities:

  • Review and approve pre and post manufacturing and packaging records to ensure compliance with cGMPs and company standards.
  • Maintain and issuance of master batch records to manufacturing floor.
  • Perform batch reconciliations and filling reconciliations
  • Prepare packaging specifications for finished product fill and assembly.
  • Maintain label inventory for various products.
  • Ensure labels and documentation are prepared for finished product being filled.
  • Perform room and equipment releases for production and packaging lines.
  • QA/Document Control Functions.
  • Assist in the maintenance of SOPs including filing, scanning, distribution and clerical revisions.
  • Assist in the maintenance of Batch Records and Packaging Line Sheets as required to maintain current cGMP compliance.
  • Aid in the filing and maintenance of customer complaints, CAPAs, deviations and investigations.
  • Fill in for Quality Assurance Inspector in monitoring Packaging Lines when required.
  • Manage own employee training records as current.
  • Collect and prepare all final packaged customer samples for shipment.
  • Keep Manager informed of all key quality findings and issues.
  • Other duties as assigned.

Qualifications:

  • HS Diploma and minimum of 3 years of experience in QA/QC or Bachelor’s degree and 1 year experience.
  • 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. Good written and oral communication skills.
  • Detail oriented.
  • Collaborative working style. Demonstrates professionalism, cooperation and willingness to support team and company priorities.
  • Well-developed interpersonal skills.  Ability to get along with diverse personalities.

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.

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. 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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