Study Director - Packaging

Job Summary

The Study Director has overall responsibility for the technical conduct of all assigned tests as well as for the review, interpretation, analysis, documentation, and reporting of results. The study director is the single point of study control. The study director ensures all assigned studies are completed on time.

Essential Duties

• Ensure reports are compliant with current procedures.
• Ensure final reports accurately reflect the data, results, and conclusions of the testing.
• Act as a final signature for assigned studies.
• Collaborate on Customer Specification Sheets (CSS) etc. as assigned.
• Ensure sample and data traceability are maintained throughout testing.
• Ensure calculations and statistics accurately reflect the raw data.
• Ensure accuracy of raw data.
• Ensure test controls and monitors are accurately recorded and reviewed.
• Collaborate within the Quality Event (QE) process.
• Read and maintain an understanding of validation procedures.
• Collaborate with document owners on Standard Test Procedures (STP) as assigned.

Regulatory Compliance

• Know and follow applicable regulatory requirements (GMP, GLP, ISO, etc.).
• Know and follow company policies and procedures.
• Ensure that test procedures are approved, communicated to, and followed by analysts.
• Ensure all data are accurately and concurrently recorded.
• Ensure unforeseen circumstances or events are recorded and that corrective action is taken.
• Complete required training on time.

Customer Service

• Uphold the NL service standard.
• Communicate regularly with sponsors as needed to relay study updates and CSS details.
• Maintain a general understanding of company pricing and credit policies.
• Review and update study information in CRM and/or other laboratory systems.

Project Management

• Coordinate workflow to ensure sponsor expectations are met.

Competencies of this position

• Technical Knowledge of laboratory testing, equipment, procedures, and basic math sufficient to direct and oversee assigned testing.
• Ability to follow written procedures.
• Good documentation practice (GDP).
• Effective critical thinking, problem-solving, and decision-making skills.
• Able to learn and comprehend difficult tasks.
• Able to troubleshoot problems.
• Adequate attention to detail.
• Effective computer skills: Microsoft Office and laboratory systems.

Values

• Ability to work in a team environment, including the ability to give and receive feedback.
• High standards of honesty, integrity, and quality.
• Willingness to identify and communicate process improvement ideas.
• Customer-focused attitude.
• Strong work ethic and initiative.

Professional

• Effective communication skills: verbal, written, and active listening.
• Able to organize and manage workload.
• Able to meet deadlines.

Education And Experience Requirements

• B.S. degree (life science strongly preferred) or A.A./A.S. or equivalent* and two years NL laboratory experience*, or High School diploma or GED, five years NL laboratory experience* in addition to demonstrate proficiency for test coordination.
• Successful completion of Study Director Training.

Work Environment

• This job operates in a professional laboratory environment.
• This role routinely uses standard office equipment and lab equipment including but not limited to computers keyboards, computer mouse, telephones, photocopiers, file cabinets, microscopes, micropipettes, pipette aids, various hand tools, and analytical equipment.
• The possibility exists for exposure to biological and chemical hazards, exposure to carcinogenic compounds and other environmental aspects which may be considered unfavorable.
• Employees are expected to follow Biosafety and Chemical Hygiene policies, practices and procedures.

Physical Requirements

• The physical demands described here are a representative of those that must be met to perform the essential job functions.
• Stand and traverse to various office and lab locations and sit at a computer workstation will vary.
• Bending, stooping, and crouching.
• Occasional push and pull tasks with one or both hands.
• Must be able to work while wearing personal protective equipment such as safety glasses, goggles, face shields, gloves, lab coats and personal protective equipment deemed necessary to protect testing and to protect employees from various solutions, wastes, etc.
• Must be able to lift up to 45lbs.

Sotera Health

• Sotera Health goes to market through its three best-in-class businesses – Sterigenics®, Nordion® and Nelson Labs®.
• Sterigenics is a leading global provider of outsourced terminal sterilization and irradiation services for the medical device, pharmaceutical, food safety and advanced applications markets.
• Nordion is the leading global provider of Co-60 and gamma irradiators, which are key components to the gamma sterilization process.
• Nelson Labs is a global leader in outsourced microbiological and analytical chemistry testing and advisory services for the medical device and pharmaceutical industries.