Sr. Documentation Specialist

Location: Buena, NJ

 

Reporting Relationships: Individual Contributor

Essential Responsibilities:

  • Possess a strong understanding of GMP compliance and requirements as they apply to quality systems.
  • Strong understanding of 21 CFR parts 210 and 211.
  • Strong understanding of working with controlled documents in a cGMP regulated environment.
  • Processes, publishes and archives controlled documents including Standard Operating Procedures (SOPs), Methods, Specifications and Protocols per Company procedures.
  • Processes and prepares investigation reports on Customer Complaints.
  • Prepares metrics on change control and other quality systems.
  • Process Change Controls from initiation through closure.
  • Maintains controlled documents in an audit ready format and in a readily retrievable status.
  • Maintains tracking spreadsheets and logbooks used by QA Doc Control. Assigns and archives logbooks from other departments as required.
  • Reviews and compiles data from Quality Systems including change controls, deviations and CAPAs and for distributed products from SAP and LIMS.
  • Provides subject matter expert (SME) support during audits with regards to Quality Documentation.
  • Maintains Quality Assurance Documentation Manager and Director of Quality Assurance informed of all adverse product quality findings and trends.
  • Performs other duties as assigned.
  • Recognizes the need for urgency in the responsibilities and makes attempts to meet all requirements and deadlines.
  • Takes initiative to identify and correct any areas of risks/gaps in the current quality systems.
  • Collaborative working style. Demonstrates professionalism, cooperation and willingness to support team and company priorities

Qualifications:

  • Bachelor’s degree in a related science (Chemistry, Biology, Physics, Life Sciences, Engineering, etc.).
  • Minimum of 10 years’ experience in the pharmaceutical, life sciences, chemical, or similar industry.
  • Solid Demonstrated ability to work on multiple projects and meet timelines.
  • Knowledge of cGMP requirements. Practical experience with document control, and QA support in pharmaceutical manufacturing.
  • Works collaboratively with other in the department and with other departments.
  • Must have a positive, supportive and can-do attitude.
  • Strong knowledge of Microsoft Word, Excel and Acrobat (PDF) documentation systems.
  • Experience with LIMS administration activities desirable.
  • Must be reliable with respect to accuracy and completeness of work assignments.
  • Must be reliable with respect to attendance schedule, on-time arrival and diligent/productive work ethic throughout the day.
  • Excellent organizational and planning skills.
  • Strong written, verbal, and interpersonal communication skills.
  • High attention to detail.
  • Demonstrated strong analytical skills, and the ability to work independently against competing deadlines.
  • Trending experience preferred.
  • Adheres to Teligent’s standards of business conduct.

Physical Demands/Factors:

The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job.

  • While performing the duties of this job, the employee is regularly required to talk or hear.
  • The employee frequently is required to stand; walk; use hands to handle or feel; and reach with hands and arms.
  • The employee is occasionally required to sit; climb or balance; and stoop, kneel, crouch or crawl.
  • Specific vision abilities required by this job include close vision, distance vision, color vision, peripheral vision, depth perception and ability to adjust focus.
  • The employee must be able to wear all required PPE, including safety glasses, ear plugs, and safety shoes.

Apply Online