Document Control Specialist

Job Summary

We are looking for a Document Control Specialist with experience in the FDA industry either with a biotech, pharma or medical device company. Candidate will be working to streamline documents from several quality management systems including Oracle (lot traceability), Maximo, Labvantage and Master Control.

Our Technical Writer/Document Controller will...

Manage the current document control system, which contains Policies, Standard Operating Procedures (SOPs), Work Instructions, Templates, Quality Records, and events, etc. Collaborate with cross functional teams to develop and implement comprehensive QA/QC strategies, processes, and Standard Operating Procedures in line with FDA Regulations, including 21CFR Part 11. Ensure and maintain site compliance with good documentation practices and TPMP data integrity requirements. Create and enhance procedural and operational documentation as required.

We Need People Who...

Have excellent technical writing and editing skills, with a keen eye for detail and the ability to translate complex information into clear, concise, and user-friendly documentation. Have experience with document control management and related systems. Exhibit attention to detail and organizational skills. Are proficient in using documentation tools and software (Microsoft Office Suite, Adobe Acrobat, etc.). Understand and are experienced in good documentation practices and ALCOA+ principles. Can communicate clearly and respectfully, both verbally and in writing, with individuals at all levels of the organization.

This role requires a Bachelor's Degree and 3+ years of experience with quality systems in an FDA regulated manufacturing or pharmaceutical environment.

location: Mebane, North Carolina

job type: Permanent

salary: $70,000 - 85,000 per year

work hours: 9am to 6pm

education: Bachelors

Responsibilities

We are looking for a Document Control Specialist with experience in the FDA industry either with a biotech, pharma or medical device company. Candidate will be working to streamline documents from several quality management systems including Oracle (lot traceability), Maximo, Labvantage and Master Control.

Our Technical Writer/Document Controller will...

Manage the current document control system, which contains Policies, Standard Operating Procedures (SOPs), Work Instructions, Templates, Quality Records, and events, etc. Collaborate with cross functional teams to develop and implement comprehensive QA/QC strategies, processes, and Standard Operating Procedures in line with FDA Regulations, including 21CFR Part 11. Ensure and maintain site compliance with good documentation practices and TPMP data integrity requirements. Create and enhance procedural and operational documentation as required.

We Need People Who...

Have excellent technical writing and editing skills, with a keen eye for detail and the ability to translate complex information into clear, concise, and user-friendly documentation. Have experience with document control management and related systems. Exhibit strong attention to detail and organizational skills. Are proficient in using documentation tools and software (Microsoft Office Suite, Adobe Acrobat, etc.). Understand and are experienced in good documentation practices and ALCOA+ principles. Can communicate clearly and respectfully, both verbally and in writing, with individuals at all levels of the organization.

This role requires a Bachelor's Degree and 3+ years of experience with quality systems in an FDA regulated manufacturing or pharmaceutical environment.

Qualifications

Experience level: ExperiencedMinimum 5 years of experienceEducation: Bachelors (required)

Skills

Documentation Control (3 years of experience is required)quality systems (3 years of experience is required)ALCOA (1 year of experience is required)FDA (3 years of experience is required)pharmabiotechmedical deviceTraining

Equal Opportunity Employer: Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.

At Randstad Digital, we welcome people of all abilities and want to ensure that our hiring and interview process meets the needs of all applicants. If you require a reasonable accommodation to make your application or interview experience a great one, please contact HRsupport@randstadusa.com.

Pay offered to a successful candidate will be based on several factors including the candidate's education, work experience, work location, specific job duties, certifications, etc. In addition, Randstad Digital offers a comprehensive benefits package, including health, an incentive and recognition program, and 401K contribution (all benefits are based on eligibility).

Applications accepted on ongoing basis until filled.