QC Raw Material Analyst

Company Description

Eurofins Scientific is an international life sciences company, providing a unique range of analytical testing services to clients across multiple industries, to make life and our environment safer, healthier and more sustainable. From the food you eat, to the water you drink, to the medicines you rely on, Eurofins laboratories work with the biggest companies in the world to ensure the products they supply are safe, their ingredients are authentic and labelling is accurate.

The Eurofins network of companies is the global leader in food, environment, pharmaceutical and cosmetic product testing and in agroscience Contract Research Organisation services. It is one of the market leaders in certain testing and laboratory services for genomics, discovery pharmacology, forensics, advanced material sciences and in the support of clinical studies, as well as having an emerging global presence in Contract Development and Manufacturing Organisations. It also has a rapidly developing presence in highly specialised and molecular clinical diagnostic testing and in-vitro diagnostic products.

In over 30 years, Eurofins has grown from one laboratory in Nantes, France to 58,000 staff across a decentralised and entrepreneurial network of 900 laboratories in over 54 countries. Eurofins companies offer a portfolio of over 200,000 analytical methods to evaluate the safety, identity, composition, authenticity, origin, traceability and purity of biological substances and products.

In 2021, Eurofins generated total revenues of EUR 6.72 billion, and has been among the best performing stocks in Europe over the past 20 years.

Job Description

QC Raw Materials and Control, will be responsible for all raw materials inspection, sampling and testing in support of clinical and commercial viral vectors products in compliance with GMP requirements. This role also will support QC sample management for GMP raw materials and QC samples (In-process, DS, and DP).

Primary Responsibilities

·Perform routine release sampling and managing testing of raw materials, such as compendial analysis per USP, Ph.Eur., and JP monographs and general chapters, based on cGMP and internal procedures

·Performs wet chemistry, use of FTIR, Raman, Near-IR analysis and other compendial assays.

·Ensures inspection, testing and release timelines are met. 

·Ensures that the integrity and accuracy of all laboratory documents are maintained; adheres to all SOP (Standard Operating Procedure), GLP (Good Laboratory Practice) and cGMP (current Good Manufacturing Practice) and regulatory requirements.

·Supports raw material qualification program by ensuring proper documentation of raw material qualification testing status

·Develops and reviews non-compendial method qualification protocols and reports

·Creates and/or revises SOPs and RM specifications

·Prepares sample reconciliation reports and other reports as needed

·Cross functional communication and routine interaction with stakeholders or various departments for oversight of in-coming QC raw materials

·Coordinate with all contract testing laboratories (CTLs) for QC RM testing activities including but not limited to obtaining quotes and POs, scheduling testing and shipments to meet timelines

·Manages data packages from CTLs for meeting timeline: tracking sample shipments, monitoring test process, creating data packages and ensuring data review accuracy

·Implements and manages appropriate QC systems for data compliance and data management

·Takes ownership of initiated Change Control Records, Non-Conformance Investigation and CAPA records

·Participates in deviation investigations related to QC RM and CTL data results

Qualifications

Must-Have/Required

·BS or BA degree in Biological Science or other relevant degree, with 2+ years  or 4+ years related experience in raw material and bio-pharma

·Technical knowledge and experience in relevant areas of 21CFR, ICH, USP, Ph. Eur. and FDA guidance documents as well as cGXPs in support of clinical and commercial manufacturing

·Proven knowledge in cGMP raw material program (RM sampling plans and testing requirements)

·Excellent project management and organizational skills, with attention to detail

·Excellent oral and written communication skills. Ability to communicate professionally with vendors, internal customers and sales professionals regarding quality issues

·Demonstrated proficiency in Microsoft Office suite

·Proven ability to handle multiple tasks concurrently, and in a timely fashion

·Outstanding interpersonal skills, highly collaborative within a multi-discipline team and contribute to a supportive and positive work environment

·Dedicated and self-motivated and engaged to learn new methodologies or provide recommendations for optimi