Operations Procedures, Technical Writer

Job DescriptionJob DescriptionEQUAL 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.

CordenPharma is a leading full-service contract development and manufacturing organization (CDMO) of active pharmaceutical ingredients (APIs), excipients, and pharmaceuticals Drug Products (DP) and packaging capabilities with > 2,600 employees across the world. Our services enable pharmaceutical and biotech companies to manufacture medicines with the ultimate goal of improving people’s lives.

Our network in Europe and the U.S. offers flexible and specialized solutions across five technology platforms: Peptides, Lipids, & Carbohydrates; Injectables; Highly Potent & Oncology; and Small Molecules. We strive for excellence in supporting this network and are committed to providing the highest quality products for the well-being of patients.

SUMMARY

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.

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, 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. 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 (e.g., non-GMP vs. GMP; PSM vs. non-PSM; lab vs. plant; etc.)
• 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. Collaborates with Operations Management to prioritize implementation of incremental improvements
• 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

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.

SAFETY & ENVIRONMENTAL RESPONSIBILITIES

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.

QUALIFICATIONS

To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed 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.

EDUCATION and/or EXPERIENCE

Bachelor's degree (BA or BS) 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.

LANGUAGE SKILLS

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.

MATHEMATICAL SKILLS

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.

REASONING ABILITY

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.

CERTIFICATES, LICENSES, REGISTRATIONS

None.

PHYSICAL DEMANDS

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.

WORK ENVIRONMENT

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.

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
• Advanced skills in publishing software (e.g., Microsoft Word, Microsoft Visio, Adobe FrameMaker, etc.)
• Demonstrated ability to prioritize incoming work, work assignments and meeting 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
• Familiarity with investigation and incident response tools (e.g., cause mapping)
• Working knowledge of regulatory compliance issues in pharmaceutical manufacturing
• Facilitation skills
• Planning, implementation, and follow-up skills

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 Insurance
• Dental Insurance
• Disability Insurance
• Employee Assistance Program
• Flexible Spending Account
• Health Insurance PPO/HSA
• Hospital Indemnity Plan
• ID Theft Protection
• Life Insurance
• Paid Maternity/Paternity Leave
• Tuition Reimbursement
• Wellness Program
• Vacation – Three Weeks 1st Year
• Vision Insurance

This Posting Expires on October 19, 2024

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