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 Organization 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 Organizations. It also has a rapidly developing presence in highly specialized 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 decentralized 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.

Job Description

Under general supervision, performs work that is varied and may be somewhat difficult in character. Audits and monitors various aspects of Eurofins Advantar Laboratories, Inc. for compliance with Good Manufacturing Practices (GMP) or in support of Good Laboratory Practices (GLP) by performing essential audits and training.
This position will require working and interacting with different employees of the company. In addition, a detailed oriented and team player person is essential for this position due to high volume of work. Knowledge of electronic documentation systems is a plus as this person may be involved in the deployment of new Part 11 electronic systems and other supporting systems. Must have the ability to apply acquired knowledge of Good Documentation Practice (GDP) and GMP to daily tasks. Knowledge of cGMP, GLP, Eudralex Volume 4, and ISO regulations are a plus.

Essential Duties, Activities, and Responsibilities:

Applies GMP in all areas of responsibilities, as appropriateDemonstrates and promotes company visionPerforms all QA functions in compliance with quality policy and regulatory requirementsAudits a variety of methodologies as applied to various stages of pharmaceutical developmentVerifies accurate transcription of raw data into Reports, Certificate of Analysis, or Summary of AnalysisReviews laboratory data and executed batch records against Advantar proceduresFollows and facilitates adherence to establish quality compliance measures and respective regulatory agencies, including FDA and EU GMPsPerforms internal laboratory audits and keep management informed of identified findingsDiscusses compliance issues with responsible scientist, Project Director, or Area ManagementInteracts with clients as necessary to maintain and grow the businessRegular attendance and punctualityKeeps current with project review, closeout, and archivalWrites, formats, trains in Standard Operating Procedures and supports Quality AuditsAttends training programs as needed to satisfy regulatory requirementsSupports new quality initiatives and continuous improvementsConducts all activities in a safe and efficient mannerPerforms all other duties as assigned

Qualifications

Education/Experience:

Bachelor’s or Master’s degree in Chemistry or closely related science field from a four year college/university or equivalent education and job experience; at least one year of previous employment history in a regulatory environment such as GMP/GLP, ISO or equivalent.

Ability and/or Skills:

Solid understanding of chemistry/lab practices. Knowledge of auditing techniquesFamiliarity with at least one scientific technique (HPLC, GC, etc.)Proven ability/knowledge to work within the other groups of the companyPlanning, organization, and work management (multitasking); follow-up skillsQuality focused with good attention to detailQuality and safety mindedGood technical skills, including the ability to understand analytical methods without actually performing themInitiative and innovation abilities.Ability to work with moderate supervision upon training completion on assigned task

Cognitive Requirements:

Ability to work effectively under pressure to meet deadlinesGood negotiation and reasoning skills.Excellent written and verbal communications skills.Good judgement, decision making, and problem solving.Positive attitude and has willingness to learn

Additional Information

Position is full-time, working Monday-Friday 8am-5pm, overtime as needed.  Candidates currently living within commutable distance to San Diego, CA are encouraged to apply.

Compensation Range: $24 - $34/hr

Excellent full-time benefits including comprehensive medical coverage, dental, and vision options.

Life and disability insurance401(k) with company matchPaid vacation and holidays

 

Eurofins USA BioPharma Services is a Disabled and Veteran Equal Employment Opportunity employer.