Operations Procedures, Technical Writer

CORDEN PHARMA BOULDER INC • CO

75d

About The Position

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. 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 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.
• 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.

Nice To Haves

• Advanced skills in publishing software (e.g., Microsoft Word, Microsoft Visio, Adobe FrameMaker, etc.).
• Technical expertise in the practices and technologies used in peptide and HPAPI manufacturing.
• Knowledge of chemical processing, plant equipment, and infrastructure.
• Familiarity with investigation and incident response tools (e.g., cause mapping).
• Working knowledge of regulatory compliance issues in pharmaceutical manufacturing.

Responsibilities

• Establishes and maintains strong, transparent, and effective day-to-day working relationships between Manufacturing, R&D, internal support, regulatory groups, and CPC customers related to assigned duties.
• 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 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.
• 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.
• Participates in programs to plan, execute, review, and improve document generation business processes at CPC.
• When workload permits, assists with document generation in other departments as needed (e.g., customer proposals, etc.).
• Implements and maintains adherence to all company policies concerning environmental, health, safety, 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.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Education Level: Bachelor's degree
• Number of Employees: 1,001-5,000 employees