Sr. Operations Compliance, Technical Writer

Corden Pharma - A Full-Service CDMO; Boulder (CO); Presencial; USD 95.000 - 125.000; Jornada completa

Ventajas ofrecidas por este puesto de trabajo

401(k) matching

Health Insurance PPO/HSA

Tuition Reimbursement

Paid Parental Leave

Wellness Program

Descripción de la vacante

Corden Pharma Colorado is seeking a Sr. Operations Compliance, Technical Writer to craft regulated procedures and technical documents supporting Operations and Technical Operations.

You will ensure timely, compliant delivery of SOPs, training docs, change controls, and batch records across manufacturing processes. The role requires a bachelor’s degree with 5+ years in regulatory/compliance writing, and experience in cgmp manufacturing.

Formación

• Bachelor's degree or 5 years related experience in regulatory/compliance documentation.
• Experience in technical writing for cGMP manufacturing.
• Background in analytical chemistry or process engineering is a plus.

Responsabilidades

• Establishes and maintains relationships between Manufacturing, R&D, regulatory groups and customers related to assigned duties.
• Ensures the generation of Operations and Technical Operations documents are executed to the planned timing and quality deliverables.
• Works with departments to create documentation meeting regulatory/compliance and manufacturing requirements for CPC Colorado.
• Translates process documentation from the laboratory into CPC formatting and language; advises on detail level to meet project deliverables.
• Serves as a technical lead on documentation/projects and ensures required supporting actions are identified.
• Participates in programs to plan, execute, review, and improve document generation processes.
• Identifies opportunities to implement process improvements and facilitates updates to documentation.
• Supports and provides technical guidance on documents with other departments.
• When workload permits, assists with document generation in other departments as needed.
• Supports investigations, deviations, CAPAs, change controls, etc.
• Implements and maintains adherence to Safety, Health, & Environment, Quality, and HR policies.

Conocimientos

Regulatory compliance

Technical writing

cGMP knowledge

Documentation leadership

Educación

Bachelor's degree

Herramientas

MS Word

Visio

FrameMaker

Descripción del empleo

CordenPharma 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.

Our People Vision

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

Summary

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.

Essential Duties And Responsibilities

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 at CPC. Identifies 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

Leadership & Budget Responsibilities

Provides 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, cGMPs, and regulatory filings to provide direction to the development teams, technical teams, and Operations in the generation of Operations procedures.

EDUCATION And/or EXPERIENCE

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. Previous experience in a technical role recommended (for example, analytical chemist, process engineer etc.).

CERTIFICATES, LICENSES, REGISTRATIONS

None.

CORE COMPETENCIES

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.

• Results oriented approach to process performance
• Excellent organizational, writing, communication, and computer skills
• Knowledge of analytical equipment in both Quality Control and Development (R&D) environments and/or knowledge of chemical manufacturing process, and an in-depth knowledge of cGMP Quality Systems
• Technical writing which allows documents to be clearly followed and understood by end users
• Advanced skills in publishing software (e.g., Microsoft Word, Microsoft Visio, Adobe FrameMaker, etc.)
• Demonstrated ability to prioritize incoming work, work assignments, and to meet deadlines
• Ability to build relationships and influence and motivate others
• Ability to achieve results through the positive direction of others
• Technical expertise in the practices and technologies used in peptide and HPAPI manufacturing, and the ability to use these skills in active projects
• Knowledge of chemical processing, plant equipment, and infrastructure
• Working knowledge of regulatory compliance issues in pharmaceutical manufacturing
• Planning, implementation, facilitation and follow-up skills
• Knowledge of applicable regulatory requirements with the ability to apply this knowledge independently with minimal input from a supervisor/manager
• Supports customer communications

SALARY

Actual pay will be based on your skills and experience.

Benefits

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

EQUAL OPPORTUNITY EMPLOYER

Corden Pharma provides equal employment opportunities to all employees and applicants for employment and prohibits discrimination and harassment of any type without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state, or local laws. Corden Pharma embraces fair hiring practices.

This post will expire September 18, 2026