Job Title: Quality Systems InvestigatorJob Description This position is responsible for conducting thorough investigations into manufacturing deviations, non-conformances, and other quality issues. The goal is to identify root causes, propose corrective actions, and prevent recurrence of problems while maintaining compliance with regulatory standards. The role involves collaboration with internal Subject Matter Experts and customers to ensure timely reporting and resolution of quality incidents. Responsibilities Lead investigations into Quality Events. Perform root cause analysis using industry standards, such as 5Whys and Fishbone diagrams. Determine relevant corrective and preventative actions. Perform risk assessments to determine the safety and efficacy of products. Oversee timely completion of deviations and CAPAs. Track and trend events and deviations. Provide communication plans for ongoing deviations and CAPAs. Maintain compliance with company policies, regulatory requirements, quality specifications, safety standards, and sanitation practices. Proactively raise quality-related risks, issues, and opportunities. Support the organization in maintaining a work environment focused on quality, fostering learning, respect, open communication, collaboration, integration, and teamwork. Essential Skills Experience conducting investigations in a cGMP environment. Knowledge of basic principles, theories, laws, policies, and procedures that pertain to investigations. Strong technical writing skills. Ability to quickly and accurately type and enter data. Additional Skills & Qualifications Experience with process investigations and writing CAPAs preferred. Work Environment The role requires strong computer skills and problem-solving abilities. The candidate will work closely with cross-functional teams including Analytical, Manufacturing, Packaging, Quality, and IT personnel. The position supports a collaborative work environment that values quality, learning, respect, open communication, integration, and teamwork. Pay and Benefits The pay range for this position is $36.00 - $38.00 Medical, dental & vision- Critical Illness, Accident, and Hospital- 401(k) Retirement Plan - Pre-tax and Roth post-tax contributions available- Life Insurance (Voluntary Life & AD&D for the employee and dependents)- Short and long-term disability- Health Spending Account (HSA)- Transportation benefits- Employee Assistance Program- Time Off/Leave (PTO, Vacation or Sick Leave) Workplace Type This is a fully onsite position in Mainland,PA. Application Deadline This position will be accepting applications until Dec 16, 2024. About Actalent Actalent is a global leader in engineering and sciences services and talent solutions. We help visionary companies advance their engineering and science initiatives through access to specialized experts who drive scale, innovation and speed to market. With a network of almost 30,000 consultants and more than 4,500 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500. Diversity, Equity & Inclusion At Actalent, diversity and inclusion are a bridge towards the equity and success of our people. DE&I are embedded into our culture through: Hiring diverse talent Maintaining an inclusive environment through persistent self-reflection Building a culture of care, engagement, and recognition with clear outcomes Ensuring growth opportunities for our people The company is an equal opportunity employer and will consider all applications without regard to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law. If you would like to request a reasonable accommodation, such as the modification or adjustment of the job application process or interviewing process due to a disability, please email actalentaccommodation@actalentservices.com (%20actalentaccommodation@actalentservices.com) for other accommodation options.
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