Our client a Ft Lauderdale based cGMP manufacturer of biotechnology, whose clients include, pharmaceutical, CROs, university and research institutes, government agencies is seeking a Manager of Documentation Control & Quality Systems to supervise Document Specialists I, II, III. Performs quality review of completed manufacturing documentation, internal quality audits, deviations, stability data, validation protocols, etc.  Ensures that all documents are maintained and issued in compliance with all prevailing cGMP regulations, and ensures the compliance of all Quality Systems. Position reports to the Associate Director Quality Assurance and Regulatory Affairs. Other responsibilities include:

§       Keep records of documents requested, issued, filed, or removed, using logbooks and/or computers according to written procedures.

§       Track materials removed from files in order to ensure that borrowed files are returned.

§       Receive and distribute controlled documents to appropriate individuals and/or departments according to written procedures.

§       Assigns production lot numbers, document control numbers, color codes etc according to written procedures.

§       Maintains signature log, training records, employee orientation checklists, etc. as required by written procedures.

§       Find, retrieve, file, scan, copy or store information from paper and electronic files in compliance with written or otherwise established procedures.

§       Compile, sort and verify the accuracy of data before it is entered; detect and report errors. Check completed work for spelling, grammar, punctuation, and format.

§       Identify potential improvements to current practices and work with management to implement upgrades.

§       Performs a technical review of documentation (e.g. stability data, validation reports, etc.)

§       Write new procedures, improve existing procedures, and develop reports, etc. in order to ensure compliance with Quality Systems.

§       Supervise Document Specialist I, Document Specialist II, and Document Specialist III by the review of their tasks and communication and assessments of their work output.

§       Approve documentation per SOP QA-004 and per Management request as designee, when applicable.

Requirements:

R    BS in life sciences or related degree

R    3+ years cGMP experience in the pharmaceutical, biotechnology or medical device industry

R    3+ years experience in FDA cGMP, CFR 210 and 211 cGMPs, CFR 600 and 610

Interested?  Email your resume to Jennifer@mriweston.com