Eurofins Scientific is an international life sciences company providing a unique range of analytical testing services. They are seeking a Quality Assurance Specialist to perform audits and monitor compliance with Good Manufacturing Practices (GMP) and Good Laboratory Practices (GLP), ensuring quality across various methodologies in pharmaceutical development.
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
Qualification
Required
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
Solid understanding of chemistry/lab practices
Knowledge of auditing techniques
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
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
Preferred
Knowledge of electronic documentation systems
Knowledge of cGMP, GLP, Eudralex Volume 4, and ISO regulations
Familiarity with at least one scientific technique (HPLC, GC, etc.)
Benefits
Comprehensive medical coverage
Dental, and vision options
Life and disability insurance
401(k) with company match
Paid vacation and holidays
Since 1987, Eurofins has grown from one laboratory in Nantes, France to ca.
