Product QC Specialist

Company Description

At Eurofins Diatherix, a Eurofins company, you will participate in exciting new developments at the cutting-edge of molecular diagnostic science and technology. Our teams of dedicated professionals work together in an entrepreneurial atmosphere, providing a broad range of innovative tools and services to the clinical diagnostics and life science research markets.

Job Description

The Product QC Specialist tests in-house produced reagents and new microarray source plate oligo synthesis prints, receives raw materials, follows current quality guidelines within the QC department, and participates in continual process improvements.

Essential Duties and Responsibilities:

• QC tests in-house produced reagents and new microarray source plate oligo synthesis prints according to approved procedures.
• Develop and validate new SPV procedures. Update PC mix recipes and qualify new PCs and recipes.
• Receives CoA from external companies and completes paperwork for the release of raw materials for both Production and QC departments.
• Maintains records that demonstrate that QC testing is conducted according to approved procedures and completes the documentation of product QC batch records.
• Forms conclusions based on data and recommends if the reagent passes or fails QC testing.
• Identifies problems that may adversely affect reagent performance, corrects problems or immediately notify the supervisor, and documents all problems fully.
• Collaborates with other departments regarding issues and devise the next steps to take.
• Participates in job specific training and competency assessment reviews.
• Develops job specific training for new processes.
• Keeps workstations clean according to the cleaning policy on a daily and weekly basis.
• Observes all safety guidelines and wears personal protective equipment as necessary.
• Reports any quality deficiencies observed and makes suggestions for improving quality.
• Prepare new documents and revises and reviews all documents according to current quality guidelines.
• Develops reagent stability testing when necessary.
• Perform process improvements within the QC department.
• Help develop validation plans for incoming panels. Ensure that all necessary items are acquired to complete all necessary work in a timely manner. Conduct data analysis in order to write a validation report.
• Fulfills ordering and monthly inventory reports.
• Performs other duties as requested by the QC Manager.
• Must comply with current laboratory guidelines.

Qualifications

• Bachelor’s degree in biology or chemistry
• Must be proficient in Microsoft Office Suite.
• Knowledge of Visual Basic, Macros, Conditional Formatting and Pivot Tables.
• Be a strong team player.
• Excellent communication skills.
• Must be able to multitask and keep up in a fast-paced environment.

Additional Information

Day, M-F, 8:00 am – 5:00 pm, Full-time

• 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.

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.