What are the responsibilities and job description for the Analyst, Quality Control - Raw Materials position at The Steely Group?
This position reports to the Associate Director, Quality Control Raw Materials, and will work with others in Quality Control, Analytical Development teams, Quality Assurance, Manufacturing and CROs to support routine QC testing for Raw Materials for the manufacturing of Gene therapy products.
The Analyst will specifically support the Raw material and gene therapy program pipeline (as needed) including but not limited to Project Management of the raw material program and development of testing strategies.
Responsibilities :
Perform routine sampling, testing, and review of GMP data, used for release of raw materials as needed to support Manufacturing (MFG) deadlines.
Effectively manage time to meet key department deliverables and individual goals and objectives.
Assist in project management of new raw materials required for upcoming MFG campaigns to meet defined process milestones and timelines.
Assist in collaboration with external labs to onboard new methods to support routine testing of new or evolving raw materials at internal and external laboratories.
Assist with authoring and implementation of new methods and associated qualification documentation for clinical and / or commercial pipeline raw materials.
Assist in the evaluation of raw material analytical instrumentation. Effectively collaborate with cross-functional teams to successfully on-board new instruments, per company procedures, to the lab as required to support in-process RM Testing.
Complete laboratory investigation, change control, deviation and CAPA documentation in accordance with governing procedures, as appropriate, for internal and external testing.
Help develop, implement and sustain 5S program and lean workflows within the department to meet key department deliverables and project timelines.
Apply professional concepts, company policies and procedures to resolve routine issues.
Requirements / Qualifications :
We are looking for a motivated and detail-oriented individual with excellent problem-solving abilities.
Strong communication, interpersonal collaboration and organizational skills required.
Able to work independently with minimal supervision following a defined training period.
BS Analytical Chemistry, Biochemistry, Biophysics, or a related discipline required.
Experience with QC raw material sampling is preferred.
Experience with technical and GMP investigational writing and testing models preferred.
Knowledge of Raw Material analytical techniques- such as FTIR, UV-Vis, Osmolality, pH, NIR, Raman, Potentiometric titration is preferred.
Knowledge of USP, Ph, Eur. and JP is preferred.
Experience working with external contract labs (CMOs, CROs) is preferred.
Ability and desire to work in a fast-paced, start-up environment, with experience in a GMP operations environment preferred.
Strong computer systems knowledge or experience preferred.
