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
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 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
Position is full-time, Monday - Friday 8am - 5pm. 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 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.
