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Technical Writer 4

Wilson, NC 27893

Posted: 04/09/2024 Employment Type: Contract Job Category: Facilities Job Number: 602097 Is job remote?: No Country: United States

Job Description

Pay is commiserate with experience and ranges between $34-44/hr

POSITION SUMMARY

The technical writer is responsible for independently investigating and reporting on deviations to the manufacturing process, customer complaints on finished product, and other manufacturing problems as assigned.

PRINCIPAL ACTIVITIES PERFORMED BY THE INCUMBENT
  • Responsible for describing problems, identifying possible causes, collecting and organizing existing data, comparing causes of facts, identifying probable root causes, and determining the best solutions in order to control the manufacturing process.
  • Responsible for managing multiple deviation investigations simultaneously.
  • Provides follow up and scheduling to ensure batch release process is not impacted by outstanding deviations.
  • Ensure investigations will withstand regulatory scrutiny and are compliant with cGMP regulations.
  • Works with process experts and production personnel to fully understand and solve problems, provides technical expertise and recommends improvements.
  • Writes Impact Assessments and Investigation Reports, works within TrackWise.
  • Assigns corrective/preventive actions (CAPAs) as necessary in order to resolve problems.
  • Performs continuous reviews and follow-up on investigations to minimize overall product impact and ensure the timely disposition of product that is directly affected.
  • Informs Management on the progress of on-going investigations, provides information to and takes direction from the Deviation Review Board.
  • Utilizes Word, Excel, Documentation and other electronic systems to complete tasks.
  • Maintains compliance with company policies, training requirements, cGMPs and safety standards.

REQUIREMENTS
  • BS/BA degree (experience may be considered in lieu of degree).
  • Must have at least three years of experience in a GMP manufacturing environment, writing standard operating procedures and protocols and/or reports.
  • Requires advanced critical thinking skills
  • Must be familiar with regulatory (FDA) requirements
  • Good organizational, communication, and interpersonal skills are necessary

Notes:
  • 100% Onsite
  • Reason for the opening: New tech writer position adding to Facilities Maintenance
  • Potential for assignment extension, or conversion to FTE: Yes, based on performance and business needs.
  • Work Schedule: Mon-Fri, 8am-5pm. No OT expected
  • Preference on previous work experiences industry: Pharma
  • Interview Process: Onsite interview with Hiring Manager and 2 members of the team (1 will be the Compliance Specialist they'll be working closely with)

The staffing industry has seen an increase in people falsely representing themselves as recruiters to gather personal information from job seekers. For your safety, do not provide sensitive data to anyone you have not spoken with thoroughly and never provide banking information during the application process. Candidate safety is a top priority at Planet Pharma.

Planet Pharma and The Planet Group of Companies are equal opportunity employers. It is our practice not to discriminate against any employee or applicant based on any criteria, condition or basis protected by laws or regulations in the locations where we do business. All qualified applicants are encouraged to apply. We celebrate diversity and are committed to providing an environment of mutual respect. We believe that diversity, equity and inclusion enable us to better meet our mission and values while serving our clients across the globe. If you have a disability or handicap and would like us to accommodate you in any reasonable way, please inform your recruiter, or contact us, so that we can discuss the appropriate alternatives available.

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About Wilson, NC

Ready to take the next step in your career? Explore job opportunities in the vibrant area around Wilson, North Carolina! Known for its charming small-town atmosphere, Wilson offers a unique blend of Southern hospitality and exciting growth opportunities. With landmarks like the Vollis Simpson Whirligig Park, the Wilson Botanical Gardens, and the Arts Council of Wilson showcasing local talent, this region is a hub for creativity and community engagement. Indulge in delicious Eastern North Carolina cuisine, catch a show at the Edna Boykin Cultural Center, or cheer on the Wilson Tobs baseball team at Fleming Stadium. From outdoor adventures at Lake Wilson to exploring the eclectic shops in downtown, Wilson has something for everyone. Start your journey today by browsing our job listings and discovering the countless reasons to build your career in this charming corner of the Tar Heel State!

Although this hasn't been an issue at Planet Pharma, the staffing industry has seen an increase in people falsely representing themselves as recruiters to gather personal information from job seekers. For your safety, do not provide sensitive data to anyone you have not spoken with thoroughly and never provide banking information during the application process. Candidate safety is a top priority at Planet Pharma.