EHS Quality Coordinator - Experic, LLC : Job Details

• Date
• Department: Quality
• Reports To: AD, Quality Regulatory Affairs
• Location: Cranbury, NJ
• Classification: Full time
• FLSA Status: Exempt

SUMMARY/OBJECTIVE:

The EHS Quality Coordinator will be responsible for coordinating Environmental Health and Safety program activities and support continuous improvement for the Quality Management System (QMS) and processes at Experic facilities.

ESSENTIAL DUTIES AND RESPONSIBILITIES:

• Manages, coordinates, and monitors administrative activities of Environmental Health and Safety to ensure safe and efficient operations in accordance with established procedures and compliance with regulatory agencies and standards.
• Manage EHS compliance inspections and reports.
• Coordinate Safety Committee
• Support continuous improvement Experic's Quality ManagementSystem (QMS) and processes, including but not limited to controlled document management, event tracking, change control, CAPA, and regulatory compliance.
• Works closely with SMEs to assist in authoring and reviewing Policies, SOP's, WIs related to Experic's Quality Systems
• Works closely with the Quality Compliance Manager and AD of Regulatory & Quality on continuous improvement projects for Quality Systems related to laboratory activities.
• Helps to promote a culture of quality, compliance, and accountability mindset, including continuous improvement through the establishment of KPI metrics.
• Support auditing activities for internal and external audits.
• Prepare and present reports on the results of internal and external audits and present findings to senior management.

QUALIFICATIONS AND EXPERIENCE:

Bachelor's degree in science or other related discipline required, however, in lieu of a degree, five (5) or more years of relevant experience of working in Quality Systems and/or Quality Assurance activities may suffice.

The candidate needs to be highly motivated, well-organized, and detail-oriented who can work effectively in a fast-paced and multi-disciplinary environment.

Experience of GMP document review, change control, non-conformances, CAPAs, complaints, and Quality Management System maintenance

Understand the requirements and procedures related to Quality Assurance, Laboratory practices and Compliance.

Ability to work flexible hours as needed.

Ability to work under pressure and meet deadlines.

Demonstrated knowledge of industry regulations and best practice standards including but not limited to the following:

US Standards: 21 CFR Part 210 & 211 – 21 CFR Part 11 – 21 CFR 1300 – 21 CFR Part 820

EU standards: EU Annex 11 – EudraLex Volume 4

ISO Standards: ISO 13485 – ISO 14971 – ISO 9001

COMPETENCIES/SKILLS:

• Read, write, review and interpret documents such as standard operating procedures, manuals, work instructions, specifications, protocols, quality agreements and contracts.
• Communicate clearly in writing and orally.
• Excellent analytical, prioritization, multi-tasking, communication, strong leadership skills, and the ability to work independently with limited supervision.
• Ability to support internal and external audits (e.g., FDA, Notified Body, Customer Inspections) from a documentation perspective
• Demonstrated effective collaboration and teamwork.
• Demonstrated experience working in a cGxP environment.
• Successfully completes regulatory and job training requirements.
• Enter data into computer using software applications for data entry, data analysis, statistical analysis, and word processing.
• Work and be proficient with e-mail systems.
• Ability to perform repetitive tasks while maintaining speed of work and attention to detail without loss to production.
• Handle problems quickly and efficiently
• Excellent knowledge of basic computer tools (e.g. Office suite, Internet, email)
• Ability to communicate with department mangers

SUPERVISORY RESPONSIBILITIES:

Not Applicable

WORK ENVIRONMENT:

Standard office environment

PHYSICAL DEMANDS:

• Office Environment (standing and sitting) requiring minimal physical exertion.
• While performing the duties of this job, the employee is frequently required to stand, walk, use hands to touch, handle or feel, and talk or hear.
• The employee is occasionally required to sit and reach with hands and arms.
• Specific vision abilities required by this job include close vision, distance vision, color vision, peripheral vision, depth perception and ability to adjust focus.

TRAVEL:

Domestic travel will be required less than 10% of the time.

Salary Range:

From $82,000 – $109,000

Ready to help shape the future of Experic? Apply today!

If you're interested in this position, please email [email protected] with your resume and any relevant documentation, including proof of certifications if specified in the job description.

Be sure to include the position title in the subject line of your email.

We look forward to connecting with you!

The job demands described here are representative of those that must be met by an employee to successfully perform the functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. This job description is not intended and should not be construed to be an exhaustive list of all responsibilities, skills, efforts, or working conditions associated with the job. It is intended to be a reflection of those principal job elements essential for recruitment and selection, for making fair job evaluations and for establishing performance standards. The percentage of time spent performing the various job duties is not absolute. The incumbent shall perform all other functions and/or be cross trained as shall be determined by the sole discretion of management, who has the right to amend, modify, or terminate this job in part or in whole. This document is not a contract for employment.

EXPERIC is an Equal Opportunity Employer, and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability status, protected veteran status, or any other characteristic protected by law.

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