Corden Pharma Colorado is hiring a Technical Writer for our Operations Compliance team. You will act as the primary resource for authoring procedures and technical documents used in support of the Operations and Technical Operations Department for the manufacture of intermediate and API drug substances. This role is responsible for ensuring documents are delivered on time, in a compliant fashion, and to the standards expected by the teams that own, execute, and use them.
What You'll Do
- Establish and maintain strong, transparent, and effective day-to-day working relationships between Manufacturing, R&D, internal support, regulatory groups, and internal customers related to your duties.
- Ensure the generation of Operations and Technical Operational documents are executed to the planned timing and quality deliverables. Advise management when revision of manpower, schedules, and priorities is required.
- Work closely with departments to create documentation that meets the regulatory/compliance and manufacturing requirements directly related to the products produced and equipment operated at Corden Pharma Colorado.
- Responsibly manage the efficient transition of process documentation generated from the laboratory (or customer documentation) into the proper format and language used at our manufacturing facilities. Advise other departments on the proper level of detail required.
- Participate in programs to plan, execute, review, and improve document generation business processes. Identify opportunities for improvement based on customer need, best industry practices, and the need for internal continuous improvement.
- When workload permits, assist with document generation in other departments as needed.
- Implement and maintain adherence to all company policies concerning Safety, Health, & Environment (SHE), Quality, and Human Resources.
- Provide guidance and leadership in the generation of regulatory/compliance and manufacturing documentation related to all commercial and development products manufactured.
What We're Looking For
- A Bachelor's Degree (BA or BS) from a 4-year college or university; or 5 years of 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 work with mathematical concepts such as probability and statistical inference, and fundamentals of plane and solid geometry and trigonometry.
- Ability to apply concepts such as fractions, percentages, ratios, and proportions to practical situations.
- 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.
- Understanding that every individual is personally responsible for the safety and environmental aspects of his or her activities in the workplace. Each employee is expected to perform their job duties in a safe manner utilizing all their knowledge, training, ability, and experience.
- Adherence to clearly defined procedures, in compliance with the principles of cGMP, is required when performing operations across Corden Pharma Colorado.
At Corden Pharma Colorado, we strive for excellence. We share our passion. Together, we make a difference in patients' lives.
