Eurofins BioPharma Product Testing North America
Quality Assurance II
Eurofins BioPharma Product Testing North America, San Diego, California, United States, 92189
Overview
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 requires interacting with different employees of the company; a detail-oriented team player is essential due to a 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. 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. 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 willingness to learn Additional Information
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 USA BioPharma Services is a Disabled and Veteran Equal Employment Opportunity employer.
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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 requires interacting with different employees of the company; a detail-oriented team player is essential due to a 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. 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. 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 willingness to learn Additional Information
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 USA BioPharma Services is a Disabled and Veteran Equal Employment Opportunity employer.
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