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Documentation Specialist

4 months ago

Raritan, United States Actalent Full time

Great opportunity for candidates with experience creating and maintaining SOPs and documentation in a regulated environment

Description:

• Support the Site Instrument Officer during execution to the Site Calibration Procedure

• Performs procedural change management tasks under the direction of the Site Instrument Officer.

• Ensure the Site Calibration Procedure is followed by all in scope of the document.

• Perform documentation tasks such as entering of equipment into the calibration database and creating and revising calibration worksheets for new and existing equipment.

• Perform reviews of CMMS forms, calibration documents (internal and vendor created) and labels, as required

• Update job plans as directed by Site Instrument Officer

• Archives calibration document by use of several different software systems

• Maintain rapidly changing data in a proprietary database.

• Proven experience with complex documentation management.

• Support R&D calibrations during internal and external audits

• Perform other essential tasks, projects, and responsibilities as required.

Additional Skills & Qualifications:

• Degree in a science related field preferred but not required. The minimum education required is a high school diploma.

• Critical thinking skills and accuracy are mandatory.

• Ability to thrive in a fast-paced environment where priorities can shift frequently.

• Strong computer skills.

• Proven ability to perform as an individual or team contributor.

• Previous experience in the consumer products, pharmaceuticals, personal care industries, or other regulated environment is preferred but not required.

• Proven experience with complex documentation management and database driven computer systems is desired

• Familiarity with Microsoft Office applications

• Detail oriented, organized, and capable of working independently in a highly regulated environment

• Able to work across organizational boundaries, interfacing with multiple disciplines including Engineering, Quality, and Calibration personnel

• The ability to effectively communicate and ensure alignment between collaborative organizations is required

• Knowledge of Good Documentation Practices and Good Manufacturing Practices

About Actalent

Actalent is a global leader in engineering and sciences services and talent solutions. We help visionary companies advance their engineering and science initiatives through access to specialized experts who drive scale, innovation and speed to market. With a network of almost 30,000 consultants and more than 4,500 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500.

Diversity, Equity & Inclusion

At Actalent, diversity and inclusion are a bridge towards the equity and success of our people. DE&I are embedded into our culture through:

  • Hiring diverse talent

  • Maintaining an inclusive environment through persistent self-reflection

  • Building a culture of care, engagement, and recognition with clear outcomes

  • Ensuring growth opportunities for our people

The company is an equal opportunity employer and will consider all applications without regard to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.

If you would like to request a reasonable accommodation, such as the modification or adjustment of the job application process or interviewing process due to a disability, please email actalentaccommodation@actalentservices.com (%20actalentaccommodation@actalentservices.com) for other accommodation options.