Job Title: Quality Control Analyst II/III Location: Piscataway, NJ (onsite: some travel to South Plainfield) Hours/Schedule: Monday-Friday, 8:30AM-5:00PM (with occasional early/late hours once per month during production runs) Type: Direct Hire Compensation: $75,000-$82,000 (based on experience) Overview Join a growing biopharmaceutical company that is expanding its Quality Control operations! This is a unique opportunity to advance your career in a collaborative, cutting-edge environment where you’ll work with both late-stage clinical and commercial small molecule and biosimilar products. Candidates must bring strong GMP and regulatory knowledge, with expertise in protein chemistry and analytical troubleshooting. If you enjoy problem-solving, hands-on testing, and contributing to life-changing therapies, this role is for you. Responsibilities Execute analytical testing for in-process, raw material, release, and stability samples Perform and troubleshoot methods including HPLC (Empower), SDS-PAGE, cell-based bioassays, ELISA, capillary electrophoresis, and compendial assays Document results in compliance with GMP, ICH, and FDA standards Author and revise SOPs, QC methods, technical reports, and investigation summaries Support batch release, batch record reviews, and regulatory dossier preparation Lead and/or support laboratory investigations, deviations, OOS results, and CAPAs Participate in Quality Events and regulatory inspections (e.g., PAI) Collaborate with cross-functional teams to ensure laboratory readiness and continuous improvement Requirements Bachelor’s in Biotechnology, Biochemistry, Chemistry, or related field with 3-10+ years QC experience, depending on level: Level II: 6+ years (Bachelor’s) or 3-4 years (Master’s) Level III: 10+ years (Bachelor’s) or 8+ years (Master’s) Previous cGMP laboratory experience - required Strong Quality Control experience in a manufacturing environment Demonstrated expertise in small molecule and protein chemistry Proficiency with HPLC (Empower), SDS-PAGE, ELISA, bioassays, and compendial assays Ability to troubleshoot analytical data and interpret/report results accurately Prior experience supporting regulatory inspections and preparing data packages/dossiers Strong technical writing & documentation skills (SOPs, QC methods, reports) #M3 #LI-MM1 Ref: #558-Scientific
...Job Description Job Description Description Job Title: Entry Level Personal Assistant Company: Createify Form Location:... ...plans. ~401(k) retirement savings plan with company match. ~ Paid time off and holidays. ~ Professional development opportunities...
...ISC Healthcare is seeking a travel Mammography Technologist for a travel job in Dallas, Texas. Job Description & Requirements ~ Specialty: Mammography Technologist ~ Discipline: Allied Health Professional ~ Start Date: ASAP ~ Duration: 13 weeks ~40 hours...
...Description Tenet Massachusetts is seeking a Registered Nurse (RN) New Graduate for a nursing job in Ashland, Massachusetts. Job... ...week ~ Shift: 12 hours ~ Employment Type: Staff \n New Grad RN and Extern Programs Available! \n Hiring for all...
...as necessary. - Maintain and oversee employment policies & procedures, compensation, employee benefits, evaluations, and other HR programs. - Administer employee recruiting/exit activities (including set-up and discard of ID badges, laptop accounts, etc.) employee...
...Transformation journey enabled by Oracle Cloud ERP and EPM. You will be part of a team that... ...-led and values-driven leader at every level. To help us achieve this we have the PwC Professional... ...does not intend to hire experienced or entry level job seekers who will need, now or in...