Boulder, Colorado (US)
CordenPharma Colorado is a highly sophisticated and entrepreneurial mid-sized pharmaceutical manufacturing company located in Boulder, Colorado. Our chemists and engineers are widely recognized for their history of innovation, having developed efficient manufacturing processes for some of the world’s most complex pharmaceutical compounds. CordenPharma Colorado also is acclaimed for its flexible manufacturing facilities and experienced workforce that can handle a wide range of production techniques and volumes. Ultimately, in partnership with our customers, CordenPharma Colorado is focused on its health care mission, proudly producing medicines that help patients around the globe survive and enjoy more comfortable lives.
The Operations Procedures, Technical Writer is responsible for optimizing the process to generate Operations Procedures and 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.). 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 team that own, execute and use the documents.
ESSENTIAL DUTIES AND RESPONSIBILITIES include the following.
Other duties may be assigned.
Responsible for guidance and leadership in the generation of the regulatory/compliance and manufacturing documentation related to all commercial and development products manufactured. Uses technical knowledge of equipment, processes, cGMP’s and regulatory filings to provide direction to the development teams, technical teams and operations in the generation of operations procedures.
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 of their knowledge, training, ability and experience.
To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed in the core competencies below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
Bachelor’s degree (B. A. or B. S.) from four-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; 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.
The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
While performing the duties of this job, the employee is frequently required to stand, sit and talk or hear. The employee is occasionally required to walk; work with hands; reach above shoulder height; climb or balance; stoop, kneel, crouch, or crawl; and taste or smell. Specific vision abilities required by this job include close vision, distance vision, depth perception, and ability to adjust focus.
The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
While performing the duties of this job, the employee is occasionally exposed to wet and/or humid conditions, moving mechanical parts, and outside weather conditions. The noise level in the work environment is usually moderate.
These are the specific areas of knowledge, skill and ability that are important for successful job performance. They must be job related and consistent with business necessity.
This is an exempt position. Salary based upon the successful candidate’s qualifications and level of experience.
To apply, please click on the “Apply Here” button. An email box will open to forward a copy of your resume to our Human Resources department for review. Please include the job number and title in the subject line:
Job #1929 – Operations Procedures, Technical Writer