Quality Assurance Manager

24 hours ago


Saddle Brook, New Jersey, United States Lynkx Staffing LLC Full time
Job Summary

Lynkx Staffing LLC is seeking a highly skilled Quality Assurance Manager to join our team. The successful candidate will be responsible for managing the PPU support unit services of the QA department and ensuring compliance with corporate Quality Systems and client procedures.

Key Responsibilities
  • Perform Quality Assurance activities with minimal supervision, including document management, issuance, review, and approval of batch records, QC data, SOPs, material releases, and final product releases.
  • Assist Quality management with department needs, including implementing ongoing quality improvement processes and developing and managing quality assurance metrics for performance improvement of all teams.
  • Anticipate program release problems and take corrective action, escalating as needed, to resolve and achieve commitments.
  • Work with project managers to develop project schedules and resource allocation models for QA-related projects and other activities, such as software deployment, customer integration, and professional services validation.
  • Delegate responsibilities to direct reports (QA Associate I, II, and III) to achieve business needs, while providing ongoing support to Manufacturing processes.
Requirements
  • BS Degree in biological sciences or equivalent.
  • Minimum 5-10 years related experience in the pharmaceutical or biologics industry.
  • Understanding of current Good Manufacturing Practices (cGMPs) and Good Laboratory Practices (GLPs).
  • Working knowledge of routine laboratory operations, equipment, and systems, production processes, validation, etc.
  • Sound knowledge of aseptic processing and supporting technologies.
  • Analytical and technical troubleshooting skills are a plus.
  • Proficient with Microsoft Office Suite.
  • Excellent organizational skills and attention to detail.
  • Good verbal and written communication skills.
  • Strong team-oriented interpersonal skills are essential.
  • Strong business acumen.
  • Relevant IT skills (able to work with Visio, Microsoft Project, and Excel).
  • Ability to think strategically and tactically (detail-oriented).
  • Strong collaborative and influencing skills and ability to work well in a cross-functional, matrixed environment.
  • Analytical and problem-solving skills.
  • Strong written and oral communication skills.
  • Meeting management/facilitation skills/teamwork.
  • Ability to multi-task is essential.
  • Flexible and able to adapt to company growth and evolving responsibilities.


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