Eurofins Advantar Laboratories, Inc. needs to ensure compliance with Good Manufacturing Practices (GMP) and support Good Laboratory Practices (GLP) through audits and training, while also potentially deploying new Part 11 electronic systems.
Requirements
- 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.
- Solid understanding of chemistry/lab practices.
- Knowledge of auditing techniques
- Familiarity with at least one scientific technique (HPLC, GC, etc.)
- Good technical skills, including the ability to understand analytical methods without actually performing them
Responsibilities
- Applies GMP in all areas of responsibilities, as appropriate
- 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
Other
- Under general supervision, performs work that is varied and may be somewhat difficult in character.
- 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.
- Regular attendance and punctuality
- 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.
- 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
- Initiative and innovation abilities.
- Ability to work with moderate supervision upon training completion on assigned task
- 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
