Bloomsbury, New Jersey

Sterility Assurance Manager - Bloomsbury, NJ

Position Overview:

  • Responsible for managing all Quality Assurance and Quality Systems departments supporting all aspects of compounding sterile pharmaceuticals and regulatory compliance within the facility.
  • Operates within the legal and regulatory compliance, producing a quality product.
  • Operates the area as the manager over the QA and QS staff, coordinating roles & responsibilities and projects.

Responsibilities may include:

  • Manage QA & QS supervisors by providing learning and development where appropriate
  • Ability to make Quality decisions related to maintenance of aseptic conditions within clean rooms with a focus on Sterility Assurance during manufacturing operations
  • Manages the on-time release of batches • Manages the on-time initiation and closure of Deviations / Investigations, CAPAs, Change Controls with thorough & standardized supporting documentation
  • Manages others to ensure appropriate SOPs and training documents are in place & effective
  • Manages others to ensure the design and maintenance of the environmental monitoring program including environmental and personnel monitoring are adequate and in place
  • Manages others to ensure QuVa quality standards are met at the site so that processes are the same as other QuVa sites
  • Maintain compliance with FDA 503B and cGMP guidelines / state and federal laws
  • Prepares and submits weekly/monthly reports, prepares metrics and trends data to identify and prioritize continuous improvement opportunities
  • Manages others to maintain site documents supporting the commercial manufacturing & release of sterile injectable products
  • Manages the design and implementation of site policies and procedures
  • Escalates to VP of Quality critical issues jeopardizing manufacturing & release of a safe & effective product that meets regulatory requirements
  • Promptly communicates with Operations regarding complaints, product issues/variances
  • Enforces applicable personnel policies and procedures
  • Other duties as assigned

Qualifications:

  • Bachelor’s Degree in Life Science or other related field
  • 5-7 years prior experience in a Quality/ cGMP / FDA regulated industry
  • Minimum 5 years of supervisory or management experience required
  • Experience with aseptic techniques and appropriate gowning techniques supporting manufacturing of sterile injectable products
  • Technical writing and communication
  • Well versed in the compliance & quality requirements of 503B pharmaceutical industry and CGMP’s and have demonstrated strength in problem solving and resolution
  • Strong interpersonal skills

For immediate consideration apply today!

Questions? Please reach out to Dustin at DUSG877@kellyservices.com

#TJP2021_SPEC



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Bloomsbury, New Jersey

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