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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, , composition, authenticity, , traceability and purity of biological substances and products.
In 2024, Eurofins generated total revenues of EUR € 6,515 billion, and has been among the best performing stocks in Europe over the past 20 years.
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 appropriate
Demonstrates and promotes company vision
Performs all QA functions in compliance with quality policy and regulatory requirements
Audits a variety of methodologies as applied to various stages of pharmaceutical development
Verifies accurate transcription of raw data into Reports, Certificate of Analysis, or Summary of Analysis
Reviews laboratory data and executed batch records against Advantar procedures
Follows and facilitates adherence to establish quality compliance measures and respective regulatory agencies, including FDA and EU GMPs
Performs internal laboratory audits and keep management informed of identified findings
Discusses compliance issues with responsible scientist, Project Director, or Area Management
Interacts with clients as necessary to maintain and grow the business
Regular attendance and punctuality
Keeps current with project review, closeout, and archival
Writes, formats, trains in Standard Operating Procedures and supports Quality Audits
Attends training programs as needed to satisfy regulatory requirements
Supports new quality initiatives and continuous improvements
Conducts all activities in a safe and efficient manner
Performs all other duties as assigned
Qualifications
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 techniques
Familiarity with at least one scientific technique (HPLC, GC, etc.)
Proven ability/knowledge to work within the other groups of the company
Planning, organization, and work management (multitasking); follow-up skills
Quality focused with good attention to detail
Quality and safety minded
Good technical skills, including the ability to understand analytical methods without actually performing them
Initiative 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 deadlines
Good 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 Pay range of this position is $34/hour.
Position is full-time, Monday - Friday 9am - 6pm. Candidates currently living within a commutable distance of San Diego, CA are encouraged to apply.
Excellent full time benefits including comprehensive medical coverage, dental, and vision options
Life and insurance
401(k) with company match
Paid vacation and holidays
Eurofins USA BioPharma Services is a Disabled and Veteran Equal Employment Opportunity employer.
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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, , composition, authenticity, , traceability and purity of biological substances and products.
In 2024, Eurofins generated total revenues of EUR € 6,515 billion, and has been among the best performing stocks in Europe over the past 20 years.
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 appropriate
Demonstrates and promotes company vision
Performs all QA functions in compliance with quality policy and regulatory requirements
Audits a variety of methodologies as applied to various stages of pharmaceutical development
Verifies accurate transcription of raw data into Reports, Certificate of Analysis, or Summary of Analysis
Reviews laboratory data and executed batch records against Advantar procedures
Follows and facilitates adherence to establish quality compliance measures and respective regulatory agencies, including FDA and EU GMPs
Performs internal laboratory audits and keep management informed of identified findings
Discusses compliance issues with responsible scientist, Project Director, or Area Management
Interacts with clients as necessary to maintain and grow the business
Regular attendance and punctuality
Keeps current with project review, closeout, and archival
Writes, formats, trains in Standard Operating Procedures and supports Quality Audits
Attends training programs as needed to satisfy regulatory requirements
Supports new quality initiatives and continuous improvements
Conducts all activities in a safe and efficient manner
Performs all other duties as assigned
Qualifications
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 techniques
Familiarity with at least one scientific technique (HPLC, GC, etc.)
Proven ability/knowledge to work within the other groups of the company
Planning, organization, and work management (multitasking); follow-up skills
Quality focused with good attention to detail
Quality and safety minded
Good technical skills, including the ability to understand analytical methods without actually performing them
Initiative 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 deadlines
Good 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 Pay range of this position is $34/hour.
Position is full-time, Monday - Friday 9am - 6pm. Candidates currently living within a commutable distance of San Diego, CA are encouraged to apply.
Excellent full time benefits including comprehensive medical coverage, dental, and vision options
Life and insurance
401(k) with company match
Paid vacation and holidays
Eurofins USA BioPharma Services is a Disabled and Veteran Equal Employment Opportunity employer.
#J-18808-Ljbffr