About The Position

This position will be responsible for maintaining and facilitating the laboratory activities and routing of controlled documents, including, but not limited to, forms and Procedure documents within the electronic document management system (eDMS). This position is also the QC Labs Archivist. They will ensure that all Lab documentation follows current procedures. This position will be responsible for storage and retrieval of documents. This position will also coordinate glassware management, metrics management/reporting, logbooks and notebooks management, retain administration, BTS access support for lab personnel, stability program and scheduling support. This position will provide back-up support for their supervisor and aid in the onboarding training of employees in the QC labs.

Requirements

  • Bachelor's Degree (preferred) + 3 years' experience or HS Diploma or GED Equivalent + 7 years' experience.
  • Experience in pharmaceutical and document management areas preferred.
  • Proficient in Microsoft Word and Excel.
  • SAP and eDMS experience preferred.
  • Experience in a records management preferred.
  • Experience in a regulated environment preferred.
  • Excellent proofreading skills.
  • Excellent verbal and written communication skills.
  • Good analytical and problem-solving skills.
  • Working knowledge of Quality Assurance systems and cGMP's.
  • Physically able to lift up to 40 lbs.

Nice To Haves

  • Knowledge of PowerPoint.

Responsibilities

  • Facilitates the updating and routing of controlled documents, including, but not limited to forms and Procedure documents within the eDMS.
  • Archivist for the QC labs. Ensures all documentation for the site is stored and archived per procedure.
  • Responsibilities also include sending and retrieval of documents to and from the offsite storage as needed.
  • Provide oversight to ensure that all document requests made during internal, external and regulatory audits and inspections are retrieved in a timely fashion.
  • Functions as a contributing team member through attendance at team meetings, and department training sessions, or other informational meetings as required.
  • Actively provides input and suggestions to help analyze and resolve problems.
  • Continuously looks for ways to improve work processes.
  • May be required to provide development and training to less experienced team members.
  • Listen and be responsive to team member's needs.
  • Be willing to be flexible in the achievement of team and department goals.
  • Responsible for providing back-up support for their supervisor and aiding in the onboarding training of employees in the QC labs Documentation Department.
  • Assist in achieving environmental, health, and safety goals by working safely and observing all general plant and department safety policies.
  • Perform other duties as assigned.

Benefits

  • Paid time off (vacation, holidays, sick)
  • Medical/dental/vision insurance
  • 401(k) to eligible employees
  • Short-term incentive programs
  • Long-term incentive programs
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