Job Description

POSITION SUMMARY:

 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
• Trains other in the QA group at the discretion of the QA Management
• Keeps current with project review, closeout, and archival
• Identifies compliance issues and ensures that the quality policy/program is understood, implemented, and maintained at all levels of the organization 
• Writes, formats, trains in Standard Operating Procedures and supports Quality Audits
• Prepares, presents, or 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

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.

LEADERSHIP SKILLS 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

BUSINESS ENVIRONMENT:

The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. The employee’s primary workstation is in an office area. However, it may be located in the laboratory or manufacturing floor as required for certain job tasks. While performing the duties of this job, the employee may be exposed to toxic or caustic chemicals and/or products.

PHYSICAL REQUIREMENTS:

On an average day this position requires the ability to clearly see and focus on objects at close and far distances with good depth perception, talk or hear (95-100% of working hours or continuously); sit, use hands to handle or feel (80-94% or essentially); reach with hands and arms (50-79% or frequently); stand, walk, lift up to 25 pounds (10-49% or occasionally); climb or balance up to one hour; stoop, kneel, or crouch, (1-9% of working hours or infrequently). Employee must wear Personal Protective Equipment (PPE), when required, including but not limited to filtering face masks etc. when working in the laboratory.

Disclaimer: This position description is written as a guideline to inform employees of what is generally expected of them at this job level. The description is not intended to be all encompassing or limiting in any manner; rather, it is envisioned to add understanding and better reflect the work performed at all levels of employment. Duties and responsibilities other than those listed may be included as needed within the work group or the company as a whole.

Additional Information

EUROFINS IS A M/F, DISABLED, AND VETERAN EQUAL EMPLOYMENT OPPORTUNITY AND AFFIRMATIVE ACTION EMPLOYER.

M-F 8AM-5PM

EUROFINS IS A M/F, DISABLED, AND VETERAN EQUAL EMPLOYMENT OPPORTUNITY AND AFFIRMATIVE ACTION EMPLOYER.