Job Title: Method Development ChemistJob Description The Method Development Chemist in the Quality Department is responsible for communicating issues and progress to management regarding formulations, materials, and processes. They handle the onboarding of new formulations, including mixing and cleaning validations, and support existing formulations through change control, quality events, and corrective and preventive actions (CAPAs). Additionally, they work with laboratory personnel on method development, transfer, and validations. Responsibilities + Oversee onboarding of new formulations, including raw material reviews, lab batching, specification setting, method validation, and scale-up to production. + Investigate quality complaints and out-of-specification events, and monitor corrective and preventive actions. + Create and approve Master Manufacturing Batch Records and complete associated change controls. + Develop pilot plant capabilities for onboarding and investigative needs. + Support validation plans, equipment and process reviews, and develop qualification test plans and protocols. + Support the CAPA program and ensure completion and response. + Create complex reports and attend meetings to communicate updates. + Represent the company positively during customer and vendor site visits. + Perform method development, transfer, and validation activities for the chemistry lab. + Assist with daily chemistry activities and product testing, including GC and HPLC. Essential Skills + Experience in formulation, method development, and validation. + Knowledge of FDA, ISO, and EPA regulations. + Proficiency in analytical instrumentation such as HPLC and GC. + Understanding of Good Manufacturing Practices. + Proficiency in Microsoft Office and statistical software (Minitab preferred). + Strong interpersonal, presentation, and communication skills. + Detail-oriented, quick learner, and creative problem solver. + Excellent organizational skills and ability to react quickly to unexpected occurrences. + Positivity, initiative, self-motivation, and ability to work independently and as part of a team. Additional Skills & Qualifications + Bachelor's degree in Engineering or Sciences (Chemistry preferred) and 10+ years' experience in an FDA-regulated Medical Device or Pharmaceutical manufacturing Quality department. + Preferred certifications: CQE, CQA, Six Sigma, and/or Lean. Work Environment The work environment includes a normal manufacturing setting with occasional lifting of up to 40 pounds. Reasonable accommodations can be made for individuals with disabilities. The company offers great opportunities for learning and growth, particularly in quality assurance and manufacturing processes. The positive work environment focuses on safety, quality, and employee well-being, with improvements in workplace culture and investment in employee training. Employees appreciate the collaborative environment and the chance to work with a dedicated team. Pay and Benefits The pay range for this position is $35.00 - $45.00 Eligibility requirements apply to some benefits and may depend on your job classification and length of employment. Benefits are subject to change and may be subject to specific elections, plan, or program terms. If eligible, the benefits available for this temporary role may include the following: - 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 Greenville,SC. Application Deadline This position will be accepting applications until Dec 20, 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.