Document Control Manager

Location
San Diego, California
Posted
Sep 28, 2021
Ref
ohDHgfwB
Hotbed
Biotech Beach
Required Education
Bachelors Degree
Position Type
Full time

Company Overview

 Avidity Biosciences is pioneering a new class of oligonucleotide-based therapies called AOCs designed to overcome the current limitations of oligonucleotide therapies in order to treat a wide range of serious diseases. We utilize our proprietary AOC platform to design, engineer and develop therapeutics that combine the tissue selectivity of monoclonal antibodies (mAbs) and the precision of oligonucleotide-based therapies in order to access previously undruggable tissue and cell types and more effectively target underlying genetic drivers of diseases. We are passionate about the impact of every employee in bringing these potentially transformative therapeutics to patients in need. Make a difference with us.

Job Summary

The Manager Document Control will oversee document control management and training program activities to ensure GxP compliance. The position pertains to processing and maintaining GxP documents and records, quality management systems records and logs, management of an electronic management system (EDMS), periodic review of SOPs and archival of quality records, and managing GxP training program, including new hire onboarding.

Essential Duties and Responsibilities
  • Manage and maintain company’s EDMS and an Administrator to assign access and tasks
  • Manage and maintain GxP controlled documents including the management of new/revised SOPs
  • Perform routine Document Control duties independently including processing QMS documents, change control, format of documents, route/track document review and approval, and issue effective documents
  • Assist in generation/revision of SOPs and documents, cross reference documents, assess impact, and ensure accuracy
  • Develop Document Control Training for new/existing employees, and establishing and maintaining employee training files, including on-boarding/off-boarding
  • Establishing training curriculum record of GxP employees
  • Perform and manage training records and ensure compliance to established SOPs and regulations
  • Issuance and oversight of log records and numbers
  • Develop and report Document Control and Training metrics and reports
  • Manage document periodic review process and document archival
  • Perform other duties as required

Qualifications

To perform this role successfully, an incumbent must be able to perform each essential duty satisfactorily. The preferred requirements listed below are representative of the skills, knowledge, and/or abilities required.  Reasonable accommodation may be made to enable individuals with disabilities to perform the essential functions.

Preferred Education and/or Experience

  • Minimum Bachelor’s degree in a relevant scientific discipline or equivalent
  • Minimum of 5 years of pharmaceutical industry experience in biopharma document management
  • Experience in EDMS Administration; part 11 compliant software system
  • Experience in managing and maintaining Document Control systems and training program
  • Strong knowledge of GMPs/FDA regulations and regulatory inspections
  • Strong communication and interpersonal skills
  • Ability to multi-task, prioritizes, meets deadlines, and work in a fast-paced environment
  • Strong initiative, detail oriented, and well organized
  • Team player, professional demeanor, enthusiastic, and self-motivated

 Avidity is committed to complying with federal, state and local law on employee vaccinations.  Job candidates should be aware that full vaccination against COVID-19 may be required in the future.    Avidity is an equal opportunity employer and encourages potential or current employees to request a reasonable accommodation under federal, state and local regulations, should one be needed.