Manufacturing Project Coordinator (428)

Location
Cincinnati, Ohio, United States
Posted
Aug 22, 2019
Ref
428
Hotbed
BioMidwest
Required Education
Bachelors Degree
Position Type
Full time
Equal Opportunity Employer

 

 

Purpose of the Position:

Coordinate project related documentation and activities to deliver manufactured API according to prescribed schedules.

 

Key Job Responsibilities:

Responsible for the implementation of assigned procedures working within defined schedules.

Responsible for performing all work within company and cGMP regulatory compliance.

Maintain a safe work environment and following all site safety procedures.

Responsible for staying current with the prescribed training curriculum specified for the job title.

 

Project Responsibilities:

Represent Manufacturing on project related teams, communicating and delivering project expectations.

Assist in technical and safety risk assessment and the communication of such risks to the manufacturing team.

Write, assist and/or review project specific documentation, including batch records, change controls and automated methods.

Assist in the generation and review of MPO's, BOM's and other project related technical documents.

Assist in technical and safety risk assessment and the communication of such risks to the manufacturing team.

Train manufacturing teams on project specific batch records and other batch processing documents.

Order and secure project specific raw materials to be used in manufacturing processes.

Work with manufacturing Team Leaders to assure operations are performed in compliance with prescribed procedures.

Compile, review and communicate project related data to the Production and Project Management teams.

Review executed batch records

Investigate, author and close project related deviations.

Implement and close project specific CAPA's.

Monitor documentation performance and propose solutions for more efficient and improved document performance.

Revise generic documentation to keep up with industry standards and customer expectations.

 

 

Job Knowledge Required:

This is a specialist position requiring a comprehensive knowledge of the cGMP requirements for API manufacturing or pharmaceutical manufacturing.

Minimum education requirements include a science related Bachelor's degree or equivalent work experience.

In depth knowledge of chemical/biotechnology manufacturing processes and equipment.

Knowledge of core manufacturing principles such as process efficiencies, optimization, and commercial viability.

Knowledge of oligonucleotide chemistry is preferred.