Overview
Quality Control Analyst, Raw Material Jobs in Bedford, Massachusetts, USA at Planet Pharma
CONTRACT MUST HAVES:2+ years’ GMP, pharmaceutical, and/or QC raw material testing experience
Experience with
QC raw material sampling
Experience with
technical and GMP investigational writing and testing models
Knowledge of Raw Material analytical techniques- such as FTIR, UV-Vis, Osmolality, pH, NIR, Raman, Potentiometric titration
Position Summary 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 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.
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
Title: Quality Control Analyst, Raw Material
Company: Planet Pharma
Location: Bedford, Massachusetts, USA
Category: Quality Assurance – QA/QC (Data Analyst)
