Document Control Associate

2 weeks ago

Philadelphia, United States Adare Pharma Solutions Full time
Are you ready to join a growing, global drug development and manufacturing organization that puts people first? Come to Adare We work closely with our pharmaceutical industry partners during all phases of drug development and commercial manufacturing with a mission of improving the lives of patients and medicines essential to people all over the world. Each role and every department within Adare offer you a unique, customized experience with a chance to make a real impact, and is critical to our success. With the help of people like you dedicated to our mission, Adare is transforming lives by transforming drug delivery

Join our mission at Adare

What can Adare offer you?

  • Medical/dental/vision/life - low employee premiums
  • 401k with a highly competitive match
  • Generous PTO, including floating holidays
  • Career growth and internal opportunities
  • Tuition reimbursement
  • Relocation assistance
  • Performance-based bonus
  • Employee Recognition Programs

We are seeking to hire a Document Control Associate to join our Quality Team.

If any of the below describes you, we would love to meet you

Responsibilities And Learning Opportunities

  • Issue and print Batch Manufacturing Records to production to align with the manufacturing schedule at various sites.
  • Maintain the appropriate files and logs.
  • Review documentation for completeness.
  • Process, track and retrieve SOPs, protocols, reports, policies, etc. using an electronic document management system. This includes obtaining electronic review and approval of documentation.
  • Prepare SOP's being made effective. Supersede or obsolete previous revisions.
  • Update SOP Book Sets accordingly
  • Control the issuance/distribution of SOP attachments and other executable documentation. Track and document accordingly.
  • Prepare and track various documents for training.
  • Compile documentation related to manufacturing changes for Annual Product Reviews (APRs). Also, scan, bookmark and archive APRs. Scan documentation and prepare for archival. Log and prepare documents for destruction.
  • Utilize the retention database to enter and retrieve records. Box up and relocate archived boxes of documents to/from various site locations.
  • Prepare logbooks according to SOP's. Issue to applicable departments and maintain tracking log. Archive completed logbooks. Maintain physical files, paper book sets and master files.
  • Process, distribute, file, track, retrieve, copy and archive a variety of documents manually when needed.
  • Distribute documents to various departments within the company and document accordingly.
  • Provide administrative and clerical support. Perform other duties as assigned.

Requirements

  • College degree preferred with some related experience or High School diploma coupled with 2+ years related experience.
  • cGMP documentation experience preferred.
  • To perform this job successfully, an individual must possess excellent typing ability and computer skills as well as oral and written skills.
  • Individual must be proficient in Microsoft Office applications such as Word and Excel.
  • Electronic document management experience is preferred.
  • Strong organizational skills are necessary to manage multitask activities.
  • Detail oriented, especially with regards to proofreading, required to ensure accuracy and completeness of documentation.

Benefits

  • Medical/dental/vision/life - low employee premiums
  • 401k with a highly competitive match
  • Generous PTO, including floating holidays
  • Career growth and internal opportunities
  • Tuition reimbursement
  • Relocation assistance
  • Performance-based bonus
  • Employee Recognition Programs

Adare Pharma is an equal opportunity employer & prohibits unlawful discrimination based on race, color, religion, gender, sexual orientation, gender identity/expression, national origin/ancestry, age, disability, marital & veteran status

PRINCIPALS ONLY

NO AGENCIES OR THIRD PARTIES.

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