QA Specialist - Doc Control Metrics Mgmt.

Company Name:
Our client is a local biotech company developing novel protein therapeutics for underserved disease indications. They are seeking an experienced QA Document Specialist to join their team. This role will focus on reporting and forecasting demand for document and report generation and controls.
Responsibilities include but are not limited to
Maintain history of document report requests and forecast new demands based uopn current and future project team needs.
Participate in efforts to increase efficiencies in document control processes and deliverables.
Gather performance data for document control operations and report these monthly.
Job Requirements include:
3+ years in document control operations; preference for experience in pharma or biotech industry experience.
BA/BS degree preferred
Electronic Document Control System experience preferred
Proficiency in MS Office Applications including advanced MS Excel required.
Knowledge of relevant regulatory guidelines including 21 CRF Part 11, Part 820, ICH Q7, Q10, and ISO:13485 preferred.
Must be authorized to work in the US indefinitely to be considered and must be commutable to the greater Cambridge area.

If interested please reach out to us ASAP via this site. All resumes and correspondence will be kept strictly confidential until you choose to pursue a specific opportunity with one of our clients.

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