Sr. Operations Compliance, Technical Writer

Corden Pharma is a leading full-service Contract Development and Manufacturing Organization (CDMO) specializing in active pharmaceutical ingredients (APIs), excipients, drug products (DPs), and packaging. With around 3,000 employees worldwide, we help pharmaceutical and biotech companies manufacture medicines with the ultimate goal of improving people’s lives.

Our network, spanning Europe and the U.S., provides flexible and specialized solutions across six technology platforms:
Peptides, Lipids & Carbohydrates, Injectables, Highly Potent & Oncology, Small Molecules, and Oligonucleotides. We strive for excellence in supporting this network and are committed to delivering the highest quality products for patient well-being.

We strive for excellence. We share our passion. Together, we make a difference in patients' lives.

The Sr. 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, batch records, specifications, test methods, protocols, reports etc.) to support the manufacture of intermediate and API drug substances.

In this role, the Sr. 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.

Include the following. Other duties may be assigned.

• Establishes and maintains strong, transparent, and effective day-to-day working relationships between Manufacturing, R&D, regulatory groups, and internal and external customers related to assigned duties
• Ensures the generation of Operations and Technical Operational documents are executed to the planned timing and quality deliverables
• 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. Ensures technical requirements for the process are maintained. 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
• Serves as a technical lead on documentation/projects and ensures required supporting actions are identified to support the project implementation
• Participates in programs to plan, execute, review, and improve document generation business processes ntifies opportunities for improvement based on customer need, best industry practices, and the need for internal continuous improvement
• Identifies and drives opportunities to implement process improvements and facilitates implementation of the identified improvements through updates to necessary documentation/procedures
• Supports and provides technical guidance on documents/procedures with other departments and technical writers
• When workload permits, assists with document generation in other departments as needed
• Supports or author’s investigations, deviations, CAPAs, change controls, etc.
• Implements and maintains adherence as a technical expert to all company policies concerning Safety, Health, & Environment (SHE), Quality, and Human Resources

Provides guidance and leadership in the generation of the…