Quality Assurance Manager

3 weeks ago

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

At Lynkx Staffing LLC, we are seeking a highly skilled Quality Assurance Manager to join our team. This role will be responsible for overseeing and managing Quality Assurance Validation/Qualification activity across two manufacturing sites in Allendale, NJ. The ideal candidate will have a strong background in GMP quality programs, with experience in both clinical and commercial manufacturing. They will be responsible for managing the quality assurance validation activity, including development, implementation, and continuous improvement initiatives. This role will also involve collaborating with other Quality departments to support organizational and functional strategy. Key responsibilities include document management, review and approval of validation protocols and reports, and ensuring compliance with FDA and EMEA regulations. The successful candidate will have excellent analytical and problem-solving skills, with the ability to think strategically and tactically. They will also have strong written and oral communication skills, with the ability to work well in a cross-functional, matrixed environment. If you are a motivated and detail-oriented individual with a passion for quality assurance, we encourage you to apply for this exciting opportunity.

  • Develop and implement quality assurance validation programs to ensure compliance with regulatory requirements.
  • Manage and coordinate the activities of the validation team, providing leadership and direction to ensure that organizational and departmental goals are met.
  • Collaborate with other Quality departments to support organizational and functional strategy.
  • Review and approve GMP documents, including investigation reports, CAPA, validation protocols and reports, SOPs, and change controls.
  • Participate in internal audits, regulatory agencies, and client audits.
  • Develop and implement quality system applications, including the use of electronic applications for training, deviations, CAPA management, etc.
  • Establish and maintain relevant controls and feedback systems to monitor the operation of the department.
  • Provide technical information during tech transfer activities to ensure all quality requirements are met according to current industry standard.
  • Establish departmental KPIs in alignment with organizational goals and objectives.
  • Plan and allocate resources to effectively staff and accomplish the work to meet departmental productivity and quality goals.
  • Plan, evaluate, and improve the efficiency of business processes and procedures to enhance speed, quality, efficiency, and output.
  • Makes business decisions that are financially responsible, accountable, justifiable, and defensible in accordance with organization policies and procedures.
  • Empower employees to take responsibility for their jobs and goals. Delegates responsibility and holds staff accountable by providing regular feedback.
  • Fosters teamwork and cohesiveness among department members; expeditiously initiates conflict resolution when issues arise.
  • Creates a workplace culture that is consistent with the mission, vision, guiding principles, and values of the organization.
  • Leads employees to meet the organization's expectations for productivity, quality, continuous improvement, and goal accomplishment.
  • Leads employees using a performance management and development processes to include goal setting, feedback, and performance development planning.
  • Provides effective performance feedback through employee recognition, rewards, and disciplinary action, with the assistance of Human Resources, as necessary.
  • Maintains employee work schedules including assignments, job rotation, training, vacations and paid time off, coverage for absenteeism, and overtime scheduling.
  • Appropriately communicates organization information through department meetings, one-on-one meetings, and appropriate email, Instant Messaging (IM), and regular interpersonal communication.
  • Supervise 1-2 Direct Reports
  • Other duties as assigned.

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