Operations Compliance, Technical Writer

Corden Pharma Colorado

About The Position

The Operations Compliance, Technical Writer acts as the primary resource for authorship of procedures and technical documents used or in support of the Operations and Technical Operations Department (e.g., standard operating procedures, training documentation, change controls, risk assessments, gap assessments, maintenance documentation, etc.) to support the manufacture of intermediate and API drug substances. In this role, the Technical Writer is responsible for ensuring that these documents are delivered on time, in a compliant fashion, and to the standards expected by the teams that own, execute, and use the documents.

Requirements

Bachelor's Degree (BA or BS) from a 4-year college or university; or 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.

Responsibilities

Establishes and maintains strong, transparent, and effective day-to-day working relationships between Manufacturing, R&D, internal support, regulatory groups, and internal customers related to assigned duties
Ensures that generation of Operations and Technical Operational documents are executed to the planned timing and quality deliverables. Advises management when revision of manpower, schedules, and priorities as required
Works closely with departments summarized above to create documentation that meets the regulatory/compliance and manufacturing requirements directly related to the products produced and equipment operated at Corden Pharma Colorado (CPC)
Responsible for the efficient transition of process documentation generated from the laboratory (or customer documentation) 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. Identifies opportunities for improvement based on customer need, best industry practices, and the need for internal continuous improvement. Collaborate with Technical Operations Management to prioritize implementation of improvements
When workload permits, assists with document generation in other departments as needed
Implements and maintains adherence to all company policies concerning Safety, Health, & Environment (SHE), Quality, and Human Resources

Benefits

401(k) matching - Corden Pharma will contribute 100% of the first 6% - 100% vested after 2 years of service
Accident Plan
Critical Illness Insurance
Dental Insurance
Disability Insurance
Employee Assistance Program
Flexible Spending Account
Health Insurance PPO/HSA
Hospital Indemnity Plan
ID Theft Protection
Life Insurance
Paid Parental Leave
Tuition Reimbursement
Wellness Program
Vacation – Three Weeks 1st Year
Vision Insurance