Technical Writer in Brentwood, NC at Volt

Date Posted: 11/11/2019

Job Snapshot

  • Employee Type:
    Contingent
  • Location:
    Brentwood, NC
  • Job Type:
  • Duration:
    24 weeks
  • Date Posted:
    11/11/2019
  • Job ID:
    201424
  • Pay Rate
    $30.0/Hour
  • Contact Name
    Volt Branch
  • Phone
    (919) 829-1660

Job Description

Volt has been a leader in the Staffing Industry for 60 years and currently has more than 100 branches nationwide to serve both our clients' and candidates' needs. We connect office professionals with leading employers in the area. Whether you are looking for a contract/temporary position or a direct hire, we are here to serve you. Find out more about us by visiting www.volt.com.

Volt is an Equal Opportunity Employer.

Exciting Technical Writer position in North Raleigh with a reputable pharmaceutical company.  

Position Summary

The Technical Writer is responsible for investigating and reporting on deviations to the manufacturing process, customer complaints on finished product, and other manufacturing problems as assigned. This is a non-supervisory position that reports to the Director, Plant Operations. Interaction with all departments is required in order to understand a problem, identify root cause(s), and implement appropriate corrective and/or preventive actions in order to prevent re-occurrence. Assists Operations and Quality Assurance in determining the disposition of non-conforming in-process product, and determining if a field alert or recall is required for product that has been released

Key Responsibilities

Responsible for describing problems, identifying possible causes, collecting and organizing existing data, comparing causes to facts, identifying probable root causes, and determining the best solutions in order to control the manufacturing process.

• Works with process experts and production personnel to fully understand and solve problems, 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 review 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, Documentum and other electronic systems to complete tasks.

• Maintains compliance with company policies, training requirements, cGMPs and safety standards.

• Assist with revision to SOPs pertaining to component preparation, compounding, filling and stoppering of sterile vials, lyophilizing, capping and inspecting of product.

• Obtain and maintain aseptic gowning qualification.

• Assist area supervision with verification and documentation of production activities, including batch records, log books, etc to ensure requirements have been met.•Ensure processes and products are in compliance with all local, state, and federal rules and regulations. Oversee that processes are in CGMP compliance, and establish systems that identifies opportunities for improvement and makes constructive suggestions for change to improve process effectiveness to heighten quality. Develop knowledge of and understand regulatory requirements such as 21CFR Parts 210 and 211, cGMP’s, FDA, OSHA and other regulatory agencies.

•Personnel engaged in the manufacture, processing, packing, or holding of a drug product shall wear clean clothing appropriate for the duties they perform. Protective apparel, such as head, face, hand, and arm coverings, shall be worn as necessary to protect drug products from contamination.

Requirements

Associate degree is required with a Bachelor of Science degree preferred.

One to three years’ experience in a GMP manufacturing environment writing standard operating procedures and protocols and/or reports is also required.

Must be familiar with regulatory (FDA) requirements. Good communication and interpersonal skills are necessary.