Senior Quality Assurance Specialist

3 weeks ago

Lynchburg, United States Emerge Talent Cloud Full time

Senior Quality Assurance Specialist (Lynchburg, VA)

Department:
Quality Assurance
For over 150 years, Fleet Laboratories, a Prestige Consumer Healthcare Company, has adapted to consumer needs with creative thinking and innovative product development. We are a global leader of over 100 personal health and beauty care products that consumers have come to trust: Summer's Eve, Dramamine, Clear Eyes, Fleet Enema, Compound W, Luden's, TheraTears, DenTek and dozens more helping people look and feel their best.
The Sr. QA Specialist has responsibility for the activities of various Quality System functions. The position provides oversight and support to the compliance of the assigned quality functions within the Quality Assurance Department. The Quality Assurance Department executes and maintains oversight of the following Quality functions: Training program, Change Control, Corrective and Preventive Actions, Events, Investigations, Internal Auditing, Continuous Improvement, QA support for New Product Development, SOP review and approval, and participation / support for Audits and Regulatory Inspections.
WHAT YOU'LL DO

  • Compliance to cGMPs and Fleet's procedures and assigned Quality functions.
  • Ensures systems and processes are in place to maintain smooth operations during employee absences and staffing changes.
  • Provide leadership, direction, and support to others in the assigned Quality functions.
  • Provide cGMP and learning management system training during onboarding of new hires.
  • Regularly communicate with leadership to identify and assess the most appropriate training methodologies, activities, and support.
  • Design / create / deliver an effective and interactive training programs and associated educational materials to support the development and continuous improvement of onboarding training, a Train the Trainer program, Operations' Batch Record training, and an accelerated cGMP training program that expediates cGMP awareness to new hires who do not have prior cGMP experience.
  • Oversee change control to improve and revise learning materials to ensure materials are current, appropriate, and effective.
  • Coordinate and conduct instructor-led training sessions to support on the job training activities.
  • Provide / facilitate coaching and continual skill development sessions.
  • Ensure all employee training records are complete and up to date.
  • Report, track, trend, and audit training progress and training effectiveness.
  • Performs GMP compliance audits, develops / distributes reports, and provides follow up to ensure closure of audit observations.
  • Ensure compliance with all associated procedures.
  • Provide oversight, support, and report effectiveness of line trials.
  • Prepare annual cGMP training schedules.
  • Participate in Inspection Readiness activities. Support audits and Regulatory Inspections. Lead with strong verbal and written communication skills during inspection / audit scenarios.
  • Provides monthly reports on time for key performance indicators.
  • Support continuous improvement projects.
  • Perform other related duties as required.
EDUCATION AND EXPERIENCE YOU WILL BRING:
  • Requires the knowledge gained through a bachelor's degree in technical or science related field and three years of experience in a GMP environment, OR work experience equivalent to a minimum of ten years of experience in a GMP environment.
  • Requires strong Microsoft Office programs/applications.
  • Requires experience in learning management systems.
  • Ability to perform statistical and mathematical functions.
  • Able to understand, apply, and communicate clearly/concisely company SOPs.
  • Strong written and verbal communication skills.
  • Able to work independently.
  • Must be capable of being crossed trained in activities within the Quality department.

WHAT WE OFFER
  • Come join a manufacturing business producing familiar iconic brands that you know and use, a business that has supported the Lynchburg community for over 150 years. Take the first step toward a great career and enjoy:
  • Our wonderfully diverse and talented employees
  • A clean, air-conditioned cGMP environment
  • Our training and employee development programs helping to make tomorrow's leaders
  • Our top-notch benefits that include paid time off, 401(k) retirement savings with company match, medical, dental, vision, life and disability insurance, competitive pay, a flexible spending account, tuition reimbursement and more
  • Our stability and historically strong record of financial performance year-after-year
No Sponsorship: Applicants must be authorized to work for ANY employer in the U.S. We are unable to sponsor or take over sponsorship of an employment Visa at this time.

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