Technical Services Documentation Specialist

Location: Buena, NJ

JOB SUMMARY:

This position will support Teligent’s Technical Services group to assist in drug product life cycle management and post-approval chemistry, manufacturing, and controls (CMC ) changes.  Reports to S.V.P. of Technical Services.

ESSENTIAL FUNCTIONS:

  • Strong understanding of Product Lifecycle and post-approval chemistry, manufacturing, and controls (CMC) changes.
  • Update documents (manufacturing and filling/packaging batch records) for product life cycle management and post-approval chemistry, manufacturing, and controls (CMC) changes.
  • Write protocols, planned deviations for process improvements on the floor.
  • Initiate change controls with updates to documents for process improvements.
  • Review and gather data for distributed products from SAP and LIMS.
  • Review and gather data from Quality Systems for investigations, NCRs and CAPAs.
  • Review and gather data for materials and components used in batch manufacture from SAP and LIMS.
  • Assist in product launch activities.
  • Work collaboratively with other departments.
  • Perform other duties as assigned.

RESPONSIBILITIES:

  • Recognizes the need for urgency in the responsibilities and meets all requirements and deadlines.
  • Takes initiative to identify and correct any areas of risks/gaps in the current quality systems.
  • Is reliable with respect to accuracy and completeness of work assignments.
  • Is 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.
  • Adheres to Teligent’s standards of business conduct
  • Collaborative working style. Demonstrates professionalism, cooperation and willingness to support team and company priorities

EDUCATION AND EXPERIENCE:

  • Bachelor’s degree in a science discipline with 2-5 years’ pharma experience
  • Solid Demonstrated ability to work on multiple projects and meet timelines
  • Knowledge of cGMP requirements. Practical experience with document control.
  • Strong knowledge of Microsoft Word, Excel and Acrobat (PDF) documentation systems.
  • SAP and LIMS experience preferred
  • Trending experience preferred.

PHYSICAL DEMANDS/FACTORS:

  • While performing the duties of this job, the employee is regularly required to stand.  The employee is frequently required to walk; sit; use hands; talk; and hear.  The employee is occasionally required to reach with hands and arms; climb or balance; stoop; kneel; crouch. The employee must occasionally lift and or move up to 25 pounds.  Specific vision abilities required by this job include close vision, distance vision, and color vision.
  • 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. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

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