Sun Pharmaceuticals, Inc Specialist, QA Systems in Billerica, Massachusetts

Specialist, QA Systems

Location MA, Billerica

Job Category Quality Assurance

Employment Duration Full time

This position is located in Billerica, Massachusetts.

Summary

This position is responsible for supporting the electronic Quality Management Systems (QMS) thatare owned by QA. These systems include the Master Control EDMS, Documentum EDMS, Learning Management systems, and TrackWise. Duties include but are not limited to: system administration operations such as managing workflows to support the business needs, developing and issuing ad hoc reports, addressing system issues, and providing documentation support for all operations, including preparation and distribution of batch records; and processing, reviewing, and coordinating document changes in the EDMS.

Responsibilities and Tasks

  • Supports the creation, revision and expiration of all controlled documentation through coordinating and word processing of document changes in the EDMS

  • Supports the administration of training activities in the LMS, including scheduling and disseminating training tasks, updating training records, generating reports, etc.

  • Monitors documentation due for periodic review in the EDMS

  • Provides user support pertaining to system trouble-shooting and problem solving in electronic QMS owned by QA

  • Participates in QMS development or enhancement, when applicable, supporting validation efforts

  • Manages controlled GMP records lifecycle including archival, maintenance, and retention of paper GMP records

  • Secures and maintains e-file repositories to ensure controlled paper GMP records are adequately scanned into secured and accurate electronic pdf files

  • Coordinates the archival and retrieval of GMP records stored off-site at controlled facilities

  • Assists in the compilation, preparation and distribution of product and raw material paper master batch records

  • Provides support to assist in the collection and compilation of Quality metrics

  • Supports record retrieval and ad hoc report generation in support of the QMS during FDA inspections and customer audits

  • Performs other duties as assigned

Knowledge Skills and Abilities

  • Excellent Microsoft Office skills, including Word, Excel, and PowerPoint

  • Excellent verbal, written and interpersonal communication skills

  • Familiarity with an electronic document management system (EDMS), learning management system (LMS), or eQMS (TrackWise) preferred

  • Must be detail oriented with the ability to multitask in a fast paced environment, exhibiting flexibility and professionalism when dealing with changing priorities and assignments

  • Comprehension and awareness of the importance of achieving regulatory compliance

  • Customer driven with sense of urgency/priority in responding to customers' needs (internal and external)

  • Team player with ability to communicate and collaborate effectively with others

Education and Experience

  • BA/BS preferred, or equivalent related experience

  • Minimum 2 years related experience in a Pharmaceutical/drug (FDA Regulated) industry preferred

Physical Requirements

  • Stand, walk, sit, use hands and fingers to handle or feel, talk or hear, stoop, kneel, crouch or crawl

  • Close vision

  • Operate computer/office machines

  • Lift up to10 lbs.

Environmental Conditions

  • Office