About this role
Job Description
ATTENTION MILITARY AFFILIATED JOB SEEKERS - Our organization works with partner companies to source qualified talent for their open roles. The following position is available to Veterans, Transitioning Military, National Guard and Reserve Members, Military Spouses, Wounded Warriors, and their Caregivers. If you have the required skill set, education requirements, and experience, please click the submit button and follow the next steps. Unless specifically stated otherwise, this role is "On-Site" at the location detailed in the job post.
Position Summary
Responsible for supporting QC testing for in-process, final product, and
stability samples, including data review/verification. May assist with
method transfer, documentation, deviations, investigations, and
continuous improvement efforts.
Shift: Wed – Sat, 1:30pm – 11:30pm
Duties/Responsibilities
Perform routine testing of in-process, final product, and stability samples.
Perform testing for method transfer/validation/verification.
Perform data verification, data review and review of GMP documentation for general methods.
May perform document revision, project, CAPA and deviation/ investigation related tasks and/ or continuous improvement efforts.
Train analysts on general job duties.
Perform other tasks as assigned.
Additional Qualifications/Responsibilities
Qualifications
Specific Knowledge, Skills, Abilities
Ability to accurately and completely understand, follow, interpret and apply Global Regulatory and cGMP requirements.
Knowledge of LIMS, ELN and laboratory data analysis systems preferred.
Problem-solving ability/mentality, technically adept and logical.
Ability to communicate effectively with peers, department management and cross-functional peers.
Experience with writing technical documents preferred.
Ability to work in a fast-paced team environment, meet deadlines, and prioritize work.
Education/Experience/ Licenses/Certifications
Bachelor's degree or equivalent required, preferably in science.
2+ years of relevant analytical testing or QC experience or equivalent combination of education and experience, preferably in a regulated environment.
Demonstrated experience in cell and molecular biology techniques (e.g., cell-based assays, flow cytometry, qPCR, ELISA, and aseptic technique).
Job Safety Requirements & Essential Physical Demands
Ability to perform lifting tasks up to 20 lbs (9 kg) at floor and waist height. Ability to lift up to 10 lbs (4.5 kg) overhead as well as push or maneuver carts to transport materials between locations.
Ability to perform frequent pipetting and related laboratory tasks within a biological safety cabinet, including extended periods of seated work.
Ability to independently don, doff, and wear required personal protective equipment such as but not limited to lab coat/frock, gloves, safety glasses/face shield for prolonged periods while performing laboratory work.
Ability to safely handle and use chemical disinfectants, flammable materials, and hazardous chemicals.
Work may involve handling of dry ice, liquid nitrogen, and cryogenically cooled materials.
Ability to use step stools while reaching and handling materials.
Ability to work in a Biosafety Level 2 (BSL-2) environment.
The laboratory employee is responsible for performing work safely in accordance with EHSS procedures. This includes identifying and controlling risks, proper use of personal protective equipment (PPE), safe handling of chemicals and biological agents, compliance with waste and emergency procedures, and active participation in training and safety programs.
We hire for skills and capabilities, not just credentials – if this role excites you, but doesn’t perfectly match your resume, we encourage you to apply anyway.
Compensation Overview
Summit West - NJ - US: $34.82 - $42.19per hour
Certificates/Security Clearances/Other
Compensation Overview
Field - United States - US: $134,390 - $162,843