Pharmaceutical QC Data Reporting 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 works with the biggest companies in the world to ensure the products they supply are safe, their ingredients are authentic and labelling is accurate.

Eurofins is the global leader in food, environment, pharmaceutical and cosmetic product testing and in agroscience Contract Research Organisation services. Eurofins 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. The Group also has a rapidly developing presence in highly specialised and molecular clinical diagnostic testing and in-vitro diagnostic products.

In over just 30 years, Eurofins has grown from one laboratory in Nantes, France to 55,000 staff across a decentralised and entrepreneurial network of 900 laboratories in over 50 countries. Eurofins offers 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 2020, Eurofins generated total revenues of EUR € 5.4 billion, and has been among the best performing stocks in Europe over the past 20 years.

Job Description

• Ability to work independently and as part of a team in a fast-paced, client facing environment.
• Self-motivated, adaptable, and a positive attitude
• Excellent communication (oral and written) and attention to detail

• Compile internally and externally generated data in support of compiling CofAs and SofAs.

• Prepare and provide CofAs and SofAs for all lot release materials

• Work with members of manufacturing, QA, RA, and R/D to provide updates/status of CofAs, SofAs, testing issues, etc.

• Trend QC product release data to support lot release and regulatory filings
• Provide trending analyses to support various activities such as manufacturing investigations, and validation studies.
• Assist in the implementation and maintenance of product release and stability data trending program for each product candidate
• Prepare product annual release and stability data trending reports
• Prepare monthly release data trending reports or as required  
• Perform reference standard trending
• Perform trending of relevant systems suitability parameters
• Prepare stability trend reports
• Prepare and populate matrices (databases, spreadsheets) designed to track testing and review status of release and stability samples, lot release data, etc.
• Compile data to support QC department metrics and performance tracking
• Assist with the improvement effort of streamlining the review and release process
• Ensures compliance with applicable cGMP regulations and SOPs
• Meet specified timelines to support release and regulatory filings
• Complies with all pertinent regulatory agency requirements.
• Participates in required training activities.

Qualifications

• BS/BA in Chemistry, Biochemistry or related field and some relevant work experience
• Have a basic understanding of Microsoft Suite (Word, Excel, PowerPoint)
• 1+ years of experience working in a cGMP pharmaceutical environment preferred
• Quality Control Laboratory experience is preferred but not required.
• Must be willing and able to work 1st shift, Monday-Friday, 8am-4:30pm. Develop and drive scientific and/or business-related improvement ideas

Additional Information

Position is full-time, 1st shift, Monday-Friday 8am-4:30pm.  Candidates currently living within a commutable distance of Rensselaer, NY and the surrounding areas are encouraged to apply. Pay is between $19.50-22.50/hr

• Excellent full time benefits including comprehensive medical coverage, dental, and vision options
• Life and disability insurance
• 401(k) with company match
• Paid vacation and holidays

Eurofins is a M/F, Disabled, and Veteran Equal Employment Opportunity and Affirmative Action employer.