QA Document Control Sr. Specialist

Bristol Myers Squibb-posted 11 months ago
$82,000 - $102,000/Yr
Full-time • Mid Level
Hybrid • Bothell, WA
5,001-10,000 employees
Chemical Manufacturing
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The Quality Assurance Document Control (QADC) Sr Specialist supports the GXP Document Control operations for the BMS Bothell site, including the document change control process, issuance and reconciliation of controlled forms and logbooks and management of archival and retention of GXP Records, leads projects to support QADC programs, and owns Quality Records on behalf of QADC when required.

  • Assist with issuing production batch records, labels, and other controlled documents to support manufacturing operations.
  • Responsible for the organization of cGXP controlled document files within the Document Center and ensure that records are readily retrievable and sent off to final archive facility as needed.
  • Assist with managing the Document Center Archive room.
  • Managing an electronic document system for the JuMP site which includes reviewing and approving document change requests, troubleshooting and releasing documents to an effective state.
  • Write and revise document control procedures including participating in the development and roll-out of document control tools.
  • Follow Policies, SOPs, and work instructions to support the document approval process, assign effective dates and training workflows, and archive documents and document change requests.
  • Assist with cross-training of Document Control personnel and customers to ensure adherence with procedures.
  • Execute the process and procedures for identifying, collecting, distributing, and filing the controlled documents for the site.
  • Support internal and external audits and regulatory inspections. This may require data gathering, interviewing, or escorting auditors during the audit. Assist with document retrieval /organization support during regulatory inspections.
  • Perform Document Control metric reporting and analysis for the local site data. This may require the use of relational databases and reporting tools to collate and analyze quality data.
  • Provide communication as to the status of Quality Systems deliverables to customers, management, and stakeholders.
  • Lead Document Control Projects as needed for continuous improvement and site wide implementations.
  • Minimum of 3 years of relevant document control management experience in a cGMP/FDA regulated environment.
  • Strong communication and customer service skills.
  • Advanced technical writing skill set with the ability to critically review documents while effectively inputting and expressing Quality principles.
  • Strong computer skills with MS Office (e.g. Word, Adobe, Visio and Excel) and with Quality Systems (e.g. Document Management System, Quality Management System).
  • Must demonstrate innovative, proactive, and resourceful behaviors; committed to quality and continuous improvement.
  • Able to prioritize, manage time well, multi-task, and troubleshoot effectively.
  • Ability to work effectively and collaboratively at a fast pace with cross functional departments to finalize time-sensitive deliverables.
  • Possess project management skills.
  • Experience interacting with FDA or other regulatory agencies strongly preferred.
  • Strong knowledge of cGMPs and domestic regulatory requirements.
  • Knowledge of manufacturing quality (manufacturing, packaging, facilities, critical systems, validation, etc.).
  • Must complete tasks independently, notify manager of decisions outside of established processes and the ability to build an internal network.
  • Commitment to achieve results by applying hard work, planning and organization, knows how to get things done both through formal and informal networks.
  • Ability to manage multiple priorities simultaneously, have a strong drive, sense of urgency and orientated on results.
  • Bachelor's degree in STEM field preferred.
  • 4+ years of relevant / transferable cGMP experience preferred.
  • Experience in FDA/EMA regulations in biopharmaceuticals or cell therapy manufacturing preferred.
  • Project management experience preferred.
  • Experience with EDMS is required.
  • Demonstrated experience with quality management systems.
  • Demonstrated knowledge of at least one enterprise computer-related system used for recording of Quality System data (e.g., TrackWise, Veeva, SAP, LIMS, Documentum).
  • Medical, pharmacy, dental and vision care.
  • Wellbeing support such as the BMS Living Life Better program and employee assistance programs (EAP).
  • Financial well-being resources and a 401(K).
  • Financial protection benefits such as short- and long-term disability, life insurance, supplemental health insurance, business travel protection and survivor support.
  • Work-life programs include paid national holidays and optional holidays, Global Shutdown Days between Christmas and New Year's holiday, up to 120 hours of paid vacation, up to two (2) paid days to volunteer, sick time off, and summer hours flexibility.
  • Parental, caregiver, bereavement, and military leave.
  • Family care services such as adoption and surrogacy reimbursement, fertility/infertility benefits, support for traveling mothers, and child, elder and pet care resources.
  • Other perks like tuition reimbursement and a recognition program.
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