The Operations Procedures, Technical Writer acts as the primary resource for authorship of procedures used by the Operations Department (e.g., master batch records, process manuals, training documentation, operating manuals, etc.) to manufacture intermediate and API drug substances at CPC.
Responsible for ensuring that these documents are delivered on time, in a compliant fashion, and to the standards expected by the teams.
Establishes and maintains strong, transparent, and effective day-to-day working relationships between Manufacturing, R&D, internal support, regulatory groups, and CPC customers.
Ensures that generation of Operations documents is executed to the planned timing and quality deliverables.
Advises management when revision of manpower, schedules, and priorities is required.
Works closely with departments to create documentation that meets the regulatory/compliance and manufacturing requirements.
Responsible for the efficient transition of process documentation generated from the laboratory into the proper format and language used at CPC manufacturing facilities.
Advises other departments on the proper level of detail required for the effort at hand, ensuring that the appropriate content is included to meet the project or process deliverables.
Participates in programs to plan, execute, review, and improve document generation business processes at CPC.

Bachelor's degree (BA or BS) 4-year college or university; or at least 5 years related experience in the technical writing of regulatory/compliance and cGMP manufacturing documentation; or an equivalent combination of education and experience.
Ability to respond to detailed inquiries or complaints from customers, regulatory, or members of the technical manufacturing team.
Ability to effectively present information to top management and peers.
Must be able to speak, read, and write English.
Ability to apply basic mathematics as it relates to the generation of the manufacturing and regulatory documentation, related to the master batch record or other applicable Operations documents.
Ability to define problems, collect data, establish facts, and draw valid conclusions.
Ability to interpret an extensive variety of technical instructions in mathematical or diagram form and deal with several abstract and concrete variables.

Operations Procedures, Technical Writer

Key skills