Somerset, NJ, 08873, USA
6 days ago
QC Senior Chemist
Job Title: QC Senior ChemistJob Description We are seeking a dedicated and experienced QC Senior Chemist to join our quality control team. The primary responsibilities include raw material testing, finished product testing, stability study samples testing, analytical method validations and verifications using HPLC and GC instruments, and writing investigations, standard test procedures, and analytical method validation protocols and reports. The ideal candidate will have a strong understanding of cGMP’s, aseptic guidelines, and other regulatory requirements, and will be responsible for the review of test results for the final release of products. Responsibilities + Perform routine and non-routine laboratory testing. + Conduct raw material testing, finished product testing, and stability study samples testing using HPLC, GC, and UV spectrophotometer. + Validate and verify analytical methods for assays, dissolution, and related substances using HPLC and GC instruments. + Champion laboratory quality and compliance, maintaining current knowledge of technical and industry trends and actively communicating these to colleagues. + Write investigations, standard test procedures, analytical method validation protocols, and reports. + Lead project work, including tech transfers, method and equipment/software validations. + Assist with technical writing and other activities assigned by the QC Manager. + Review and approve QC data, monitor for trends and abnormalities, and act on data results. + Demonstrate excellent interpersonal communication with personnel inside and outside of QC. + Perform tasks typically assigned to the QC Senior Chemist role as needed. Essential Skills + Bachelor's or Master's degree in Chemistry or related Sciences. + Minimum of five years QC chemistry laboratory experience. + Minimum of three years GMP experience. + Experience with HPLC (3-5 years) and GC instruments. + Knowledge of cGMP requirements and QC operations in pharmaceuticals. + Proficiency in LabSolutions software. + Excellent written and verbal communication skills. + Strong troubleshooting skills for problematic methods, products, and instrumentation. Additional Skills & Qualifications + Self-motivated with demonstrated leadership and the ability to work independently with minimal guidance from management. + High proficiency in problem-solving, creativity, independent thought, and sound judgment. + Experience in developing others by coaching/mentoring less experienced employees and interns. + Experience supervising and overseeing the activities of employees, contractors, and interns. Work Environment This position is within a small company of about 30 people, founded in 2020. The company operates as a CDMO. The work environment includes a well-equipped laboratory with advanced technologies and instrumentation. The role involves working in a collaborative and supportive team setting, with a focus on maintaining high standards of quality and compliance. 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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