SGS North America
Document Control Specialist
At a glance
Location: US-CT-Fairfield Map
Posted: 04/10/2021
Closing: 05/09/2021
Degree: Not Specified
Type: Full-Time
Experience: At least 12 year(s)
SGS North America
Job description

Company Description  

SGS is the world’s leading inspection, verification, testing and certification company. SGS is recognized as the global benchmark for quality and integrity. It operates a network of over 2,000 offices and laboratories around the world.


Job Description  

PRIMARY RESPONSIBILITIES

The duties of the Document Control Specialist are geared toward assisting Quality Management in administering the company’s systems for document control.  A large part of the Document Control Specialist’s job consists of maintaining the company’s Operations Procedures and the company’s Form/Worksheet Control System.  Overall, the Document Control Specialist role presents the employee with an opportunity to contribute substantially to the company’s ongoing success as a quality testing laboratory.

REPORTING LINE

The Document Control Specialist in the Quality Assurance Unit at SGS Life Science Services reports to Quality Assurance Management.  The Documents Control Specialist also works closely with Analytical and Microbiology Management. 

SPECIFIC RESPONSIBILITIES

OUR PROMISE TO OUR CUSTOMERS

At all times, comply with SGS Code of Integrity and Professional Conduct, and to conduct all our testing to to the highest level of cGMP compliance.

SERVICE RESPONSIBILITIES TO CLIENTS

  • Field customer phone calls in a friendly, polite, and ultimately professional manner.
  • Direct customer inquiries to the appropriate technical staff or management.
  • Answer customer questions pertaining to administrative matters in an efficient manner that cultivates trust and reliability.
  • Greet visitors to the lab in a professional, courteous manner.
  • Respond promptly to all customer requests for specific protocols and/or SOPs.

SERVICE RESPONSIBILITIES TO INTERNAL CUSTOMERS

  • Respond to all reasonable requests from the Quality Management, as well as from Operations Management and technical staff, pertaining to document control, SOPs, protocols, forms/worksheets, etc.
  • Provide miscellaneous administrative support to management and technical staff as needed. 
  • Play a role in Departmental or company-wide projects designed to improve the internal efficiency and overall quality of work performed at the laboratory.
  • Play a role in creating and maintaining an atmosphere of teamwork throughout the laboratory.

TECHNICAL RESPONSIBILITIES 

  • Maintain thorough knowledge and understanding of all general SOPs pertaining to the laboratory.
  • Maintain thorough knowledge and understanding of GMP/GLP/ISO requirements as these pertain to work performed in the laboratory.
  • May be invited to participate in the preparation and review process for appropriate department SOPs, worksheets and data forms.

ADMINISTRATIVE RESPONSIBILITIES

  • Under the direction of the Quality Management, maintain the company’s Site and North American Operations Procedures.  Duties here include word processing SOPs, routing SOPs for routine review, maintaining a current index for each section of the Manual, assigning numbers to new SOPs, publishing and approving SOPs into the appropriate department folders, routing SOPs to other sites, and archiving SOPs
  • Assist Quality Management in maintaining the company’s Form/Worksheet Control System.  Duties here include assigning numbers to new forms/worksheets, assigning revision codes to revised forms/worksheets, and copying and filing forms/worksheets into the appropriate department binders.
  • Assist Quality Management in assigning, tracking, and brining to closure Change Control Requests.
  • Assist in managing and controlling Customer methods.
  • Assist in managing customer protocols and reports including Method Transfer, Method Validation and Stability.
  • Assist if needed in managing Quality Agreements and other legal documents including Non-disclosure and Service Agreements.
  • Compliance with GMP/GLP and ISO requirements as these pertain to document control.
  • Knowledge of and familiarity with all SOPs pertaining to the company’s administrative functions.
  • Other duties may be assigned by QA Management as needed.

Qualifications  

PROFILE

  • Minimum 12 years general education required, with an advanced degree preferred.
  • Previous office experience preferred.
  • Previous experience working in a GMP/GLP environment preferred.
  • Job requires mobile use of hands and arms.  Reasonable accommodations will be made for persons with disabilities.
  • Must be capable of working at a desk and computer terminal for up to three hours at a time, and for up to eight hours on a given day.

REQUIRED SKILLS

  • Must be detail oriented; must be precise and organized in handling of documents.
  • Must be able to think systematically; must have rudimentary problem-solving skills.
  • Knowledge of and familiarity with word processing and database software required (MS Office preferred).
  • Basic language proficiency (fundamentals of grammar and syntax) required.
  • Solid organizational skills required; must be able to prioritize multiple tasks.
  • Solid communication skills (written and verbal) essential.
  • Must be able to cooperate with others and work as part of a team.
  • Must be able to follow directions well.
  • Must be able to work with persons from diverse backgrounds.


Additional Information  

•       Safety is a top priority within SGS. Every employee within the organization has defined          HSE Duties and Responsibilities to ensure that the organization meets its objectives of          no harm to personnel, damage to equipment, or harm to the environment.

•       To perform this job successfully, an individual must be able to perform each essential              duty satisfactorily. The requirements listed above are representative of the knowledge,            skill, and/or ability required.

•       This job description should not be construed as an exhaustive statement of duties,                  responsibilities or requirements, but a general description of the job. Nothing contained          herein restricts the company’s rights to assign or reassign duties and responsibilities to          this job at any time.

SGS is an Equal Opportunity Employer.

Document Control Specialist