Sr. Quality Control Analyst (Pharma)
LNN Pace Analytical Life Sciences, LLC
Shift: Monday through Friday, 8:00AM - 5:00PM Summary Responsible for providing or overseeing the analysis, administration, and oversight of comprehensive chemistry/biochemistry policies, programs and practices; may provide feedback and guidance to clients regarding the analysis of materials, products and/or devices utilizing complex and specialized professional and technical knowledge of chemistry/biochemistry/formulation development or related equipment, testing, and procedures. Essential Functions Serve as a lead to staff, providing work direction, guidance, and training. Oversee or review, complete, and process comprehensive types of forms, documents, databases, and related materials. Provide proper documentation of practices following GxP and QC procedures. Provide complex to specialized analysis in support of various testing materials, products and/or devices utilizing various analytical instrumentation, following SOPs and methods. Provide complex to specialized review, analysis, interpretation, and documentation of testing results. Analyze and review operations, results, feedback and related chemistry/biochemistry/formulation information to determine trends, draw conclusions, and present results, proposals, and recommendations to management and/or clients. Provide training and guidance on analytical tests, methods, and instrumentation as required. Provide analysis, interpretation and counsel to clients, staff, management and functional leaders regarding chemistry/biochemistry policies, programs and practices, leading implementation and change. Assist with developing or participating in chemistry/biochemistry/formulation or cross‑functional project or program objectives, including proposed budgets, timelines, materials, personnel, and other requirements. Develop, validate and transfer analytical methods. Provide routine and non‑routine analysis using analytical techniques such as HPLC, ddPCR, ELISA, and various bioassays. Design and develop robust and scalable formulations for small molecules and biologics for early‑stage clinical trials. Ensure all activities adhere to SOPs, regulatory guidelines, GLP and GMP standards. Develop critical material qualification protocols and maintain up‑to‑date inventory of critical materials. Contribute to the efficiency and effectiveness of the department’s service to its customers by offering suggestions and participating as an active member of a work team. Promote and support the overall mission of Pace Analytical by demonstrating courteous and cooperative behavior when interacting with customers and staff, and acting in a manner that promotes a harmonious and effective workplace environment. Qualifications Bachelor’s degree in chemistry/biochemistry or a closely related field, with 5–8 years of experience in specialized or technical programs, or an equivalent combination of education, training, and experience. Master’s or PhD degree is strongly preferred. Required Knowledge and Skills Complex and specialized principles, practices, and techniques of chemistry/biochemistry and formulation development; broad understanding of the administration and oversight of chemistry/biochemistry programs, policies, and procedures; knowledge of applicable laws, codes, regulations, GxP, QC, ALCOA++ documentation; understanding of testing tools, equipment, calibration; proficiency with computer applications related to the work; and strong communication skills in business English. Required Technical Skills Perform complex to specialized professional‑level chemistry/biochemistry duties in areas such as ELISA, ddPCR, Sanger sequencing, CE‑SDS, and HPLC. Oversee and administer broad chemistry/biochemistry/formulation functions and train others on analytical instruments and manufacturing equipment. Prepare advanced to expert functional reports, correspondence, and other written materials. Conduct effective oral presentations to large and small groups across functional peers and departments. Use initiative and independent judgment within established department guidelines, employing tact, discretion, and prudence. Serve as a team member and manage projects in both team and individual contributor environments. Benefits Full‑time roles are eligible for a comprehensive benefits program including competitive salary, medical, dental, vision, 401K retirement savings plan (100% vested immediately in the employer match), life, disability, voluntary benefits, paid time off for holidays, sick and vacation days, HSA, wellness program, flexible spending accounts, tuition reimbursement, Employee Assistance program, parental leave, optional legal coverage, and ID theft protection. Equal Opportunity Employer Pace® provides equal employment opportunities to all employees and applicants for employment and prohibits discrimination and harassment of any type without regard to race, creed, color, religion, genetics, protected veteran status, national origin, sex, age, disability, marital status, sexual orientation, gender identity or expression, citizenship, or any other characteristic protected by federal, state or local laws. This policy applies to all terms and conditions of employment, including recruiting, hiring, placement, promotion, termination, layoff, recall, transfer, leaves of absence, compensation and training. #J-18808-Ljbffr LNN Pace Analytical Life Sciences, LLC
$125k - $145k
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