Jeffrey Belitsky Email & Phone Number

Pittsfield, Ma, Us

Pittsfield, Massachusetts, United States

Communicate with filmmakers regarding the screening of their selected feature and short films at the annual Boston Science Fiction Film Festival. Facilitate their participation in the festival and act as an interface between the filmmakers and the festival organization. Contribute to the continuous improvement of the organization through use of quality analysis and principles.

London, Gb

Fully responsible for production record and Equipment Use Log (EUL) issuance for the 3 buildings at the Lexington site and the scanning and storage (online and paper) of the completed documents. Prior experience in the position included batch record review and cGMP guidance to manufacturing staff.

Tokyo, Jp, Jp

Document Issuance, Maintenance of batch records, QA support of production.

Paris, France, Fr

A reviewer of batch records, I verified all aspects of the record are correct and documented properly. One of the “go to” persons on the team, I provided guidance regarding cGMP practices in the manufacturing environment. I also assisted in the identification and resolution of deviations by manufacturing, in accordance with company and government regulatory requirements.

I conducted Production facility Walkthroughs, documenting observations of non-compliant areas and opportunities for improvements. I was also a reviewer of electronic batch records for errors and omissions - following up with production areas to ensure corrections – after which I would sign off on them. I created and reviewed SOPs in accordance with current Good Manufacturing Processes (cGMP). Finally I provided guidance to manufacturing operations on documentation and deviations.

Us

Independant contactor with Clinivation, Inc. working at Olympus Gyrus ACMI in Southborough, MA. Assisted in the maintenance of regulatory files, dossiers, and folders, assembling data from multiple sites to create regulatory packages. Developed, coordinated, prepared, and maintained international device submissions for overseas markets.

Responsible for maintaining quality support, documentation of procedures coordinating company representation at trade and business events, and maintaining the company website. Administered a mass marketing email program and customer communications as a result of marketing activities.

Created documentation packages compliant with Good Manufacturing Practices (cGMP) to accompany company filtration products. Worked with customers, subcontractors and vendors to obtain necessary data and to ensure complete and legible documentation.

Performed design process audits with the intent of improving compliance to defined procedures and work instructions. Reported on non-compliances and assisted in their resolution, which involved root cause analysis and corrective actions.

As a member of the new Software Quality Assurance (SQA) team, provided major contributions to the successful effort to achieve certification as a Level 3 engagement under the Capability Maturity Model (CMM). Audited compliance to process, analyzed results, created reports, charted/graphed data, and presented results/trends to management groups.

Programming support to the Annuities department as well as implementing the annual tax package upgrades.

Ba, Psychology

Certificate, Biotechnology/Biomanufacturing