Document Control Coordinator

When our values align, there's no limit to what we can achieve.
 
At Parexel, we all share the same goal - to improve the world's health. From clinical trials to regulatory, consulting, and market access, every clinical development solution we provide is underpinned by something special - a deep conviction in what we do.

Each of us, no matter what we do at Parexel, contributes to the development of a therapy that ultimately will benefit a patient. We take our work personally, we do it with empathy and we're committed to making a difference.

PXL has an exciting opportunity for a Document Control Coordinator! This role is responsible for performing assigned site general and area specific tasks as per
requirements stated in the contract with the service provider. The ideal candidate for this role will have experience maintaining document repositories and archives.

Essential Duties and Responsibilities include, but are not limited to, the following:

• Comply with all current IOPS cGxP’s (e.g. Good Manufacturing Processes, Good
• Documentation Practices etc.).
• Complete all required training items (SOP’s, CBT’s, OJT’s ILC’s etc.) within the associated timeframes prior to performing any associated tasks.
• Performs all tasks required for work completion per approved standard operating procedures (SOPs).
• Comply with all IOP’s Environmental, Health & Safety policies / procedures associated with all tasks performed
• Will be verifying and maintaining master manufacturing documentation, logbooks and supporting documentation.
• The records management lifecycle includes developing and receiving, active use, storage (inactive use), and disposition (destroy or transfer) and is inclusive of both physical and electronic records. Records management also includes recordkeeping, data protection and privacy, information security and information disclosure requirements to ensure compliance with legal and regulatory elements.
• Review all documents for accuracy, coordinating review and revision practices.
• Maintaining systems for disseminating retention schedules.

Skills

• Review all documents for accuracy, coordinating review and revision practices.
• Maintaining systems for disseminating retention schedules.
• Very strong attention to detail and very strong written and verbal communication skills.
• Ability to work cross functionally across teams in order to collect the proper information Strong problem solver
• Ability to take on multiple tasks in order to reach deadlines
• Performing risk analysis and assessment of proposed changes to resolve risk-benefit profile
• Integrating with Security, Privacy, and Legal to ensure Records Management processes and systems align with policies owned by these areas.

EEO Disclaimer
Parexel is an equal opportunity employer.  Qualified applicants will receive consideration for employment without regard to legally protected status, which in the US includes race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.