GENERAL STATEMENT OF RESPONSIBILITY:  Responsible for assessing and documenting regulatory compliance related to CRL’s Environmental, Health, and Safety (EHS) Program, Facilities, and Logistics. Conduct routine internal audits to assess compliance and maintain all records associated with areas of responsibility.

ESSENTIAL FUNCTIONS:

• Conduct internal audits to verify adherence to regulatory requirements and conformance to CRL Policy and Procedures as they relate to safety, facilities, and logistics compliance.
• Conduct external audits of CRL suppliers to verify adherence to the contractual agreements and compliance obligations.
• Prepare formal audit reports and follow through until closure of all audit findings.
• Develop and maintain audit plans pertaining to areas of responsibility. Ensure the audit process and related procedures remain valid and effective.
• Coordinate and support safety and facilities related regulatory inspections through the following:  ensuring preparedness of all parties for the event, overseeing appropriateness of responses to audit observations and recommendations, and responding to any reported non-conformities.
• Monitor activities within the CRL laboratories to meet safety and physical facility related regulatory standards.
• Monitor the regulatory standards for updates and provide assistance to laboratories and other stakeholders to adhere to new/revised standards.
• Evaluate and record quality metrics and develop new metrics to identify performance improvement.
• Analyze and trend non-conformances and incidents to ensure that issues are resolved in a timely manner and that effective corrective actions are implemented.
• Leverage project management and quality tools to recommend and implement process improvement initiatives.
• Conduct training sessions and other information meetings pertaining to the EHS program, including new-hire training.
• Environmental Health and Safety Program Oversite

• Coordinate Department Safety Officer (DSO) program including routinely leading meetings and coordinating necessary training.

• Ensure compliance with Safety and Facilities regulations and codes and acts as primary point of contact to regulatory agency / government authorities.
• Update and maintain all policies, processes, and procedures that comprise the Safety Manual.
• Manage safety related audits, develop action plans to resolve findings and implement countermeasures promptly and effectively.
• Evaluate new hazardous materials to ensure compliance in safety requirements and facility procedures.
• Support safety components and documentation related to of Human Resources/Workers’ Compensation Program by participating in incident investigations, analysis of accident data to identify trends or areas requiring additional focus.
• Conduct ergonomic assessments.
• Report injuries and accidents to appropriate agencies.

• Maintain records and documentation related to safety, facilities, and logistics in the eQMS document control system.
• Support Environmental and Sustainability Initiatives
• Coordinate with Facilities and Logistics to conduct appropriate drills as required (i.e. evacuation drills). Prepare appropriate documentation of these events.
• Assist Corporate Quality and Logistics personnel with FDA product registration, licenses, and recall notices.
• Collaborate with corporate leadership to facilitate and implement process improvements and Preventive Action to support the performance and needs of the business and its clients.
• Prepare annual summary of the EHS program including quality metrics and progress on new and ongoing EHS and sustainability initiatives.
• Continuously improve skills through in-house training, self-study methods and other available training resources.
• Maintain and protect the confidentiality of all CRL, CRL subsidiaries, legal entities, and client information.

• Be able to comply with all applicable federal, state, and local safety and health regulations that would apply to this job.

Other duties as assigned.

 

JOB QUALIFICATIONS:

EDUCATION:  College degree (AA or BA/BS) or equivalent work experience

EXPERIENCE:  2 years of experience in a laboratory or other similar regulated environment. Knowledge of OSHA regulations. Prior industrial safety training or willingness to gain such skills upon employment. Training and/or experience performing audits preferred.

SKILLS AND ABILITIES: 

§  Excellent written and verbal communication skills

§  Strong facilitation, problem solving, training, and presentation skills

§  Displays exemplary customer service focus at all times

§  Ability to work independently with limited direction or as part of a team

§  Self-starter, organized, detail-oriented

§  High level of proficiency with Microsoft Office applications

§  Able to understand and apply new regulations

§  Must be objective, fair, and consistent with sound judgment

§  Familiarity with applicable regulations and standards (GCP, GLP, GMP, CLIA, CAP, ICH, FDA, OSHA, IATA, and ISO) helpful

§  Ability to provide training, either one-on-one or in group settings.

§  Ability to be at work and on time

§  Ability and judgment to interact and communicate appropriately with other employees, clients, and management

 

PHYSICAL REQUIREMENTS:  The physical demands described here are representative of those that must be met to successfully perform the essential functions of this job. Reasonable accommodations may be available to enable individuals with disabilities to perform the essential functions.

The following physical attributes are required for this position:

• Sitting for extended lengths of time
• Close vision requirements due to computer work
• Repetitive use of hands, fingers, wrists, and elbows for operating a computer and telephone
• Lifting up to 25 pounds
• Reaching, including above the shoulder
• Bending or stooping
• Squatting or crouching
• Kneeling
• Ability to hear auditory cues
• Periods of constant movement around the laboratory. 
• The ability to discriminate between different colors visually is considered an essential function for the position

EQUIPMENT:  Personal computer, laboratory coat, safety equipment as necessary.

OTHER:  Occasional handling of blood\urine for specimen preparation/analysis; specimens consist of body fluids and must be regarded as potentially infectious; occasional night and weekend work.  Flexible work schedule, including weekends and evenings as required as well as some travel. Hybrid work arrangement is allowed at the discretion of management.

The employer shall, in its discretion, modify or adjust this position to meet the company’s changing needs.

This job description is not a contract and may be adjusted as deemed appropriate in the employer’s sole discretion.

§  denotes essential job function

An Equal Opportunity Employer

Pay Range: $52,500 - $120,000

Benefits for Full Time Employees:

• Medical, Dental, Vision
• Life/AD&D
• Supplemental Life/AD&D
• Section 125 FSA Plan
• 401(k)
• Short and Long-Term Disability
• Paid Time Off
• Holidays
• Tuition Reimbursement