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.

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.

SUMMARY

Provides support that facilitates seamless execution of the overall objectives of the Quality Department. Supports the administration of Quality Assurance Documentation Programs, procedures, and controls, ensuring that performance and quality of products conform to established Corden Pharma Colorado (CPC) standards and federal regulations.

ESSENTIAL DUTIES AND RESPONSIBILITIES

Include the following. Other duties may be assigned.

• Provides support for the Director of QA & Control in a professional and timely manner; to include compiling and communication of KPIs, composition of departmental correspondence, distribution of departmental reports, and other duties and special projects as needed
• Accountable for submission and/or timely renewal of applicable site regulatory agency permits, registrations, and certificates
• Maintains Quality Department regulatory document master files in compliance with retention schedules and other applicable corporate and regulatory requirements. Maintains all documentation located in the Quality Retention room, which includes Master Batch Records and change control documentation for production and development operations
• Issues batch records and associated labels, by ensuring the copy is a replicate of the master production instructions for each intermediate and API
• Serves as the backup Administrator for the QA Documentation Specialist of the Quality Department records database (Tabfusion) and off-site records storage duties (Iron Mountain)
• Provides administrative support to QA and QC for site methods and specifications revisions and updates, as well as related change control documentation. Confers with chemists, engineers, and production and quality personnel regarding changes made to procedures, reports, and all other documentation. Maintains associated master files in compliance with regulatory requirements. Issues Specifications and methods to all required laboratories. 
• Proofreads documentation for completeness and adherence to CPC templates and documentation standards
• Works directly with manufacturing to review and correct executed batch records and procedures. Reviews Batch Records for products to be shipped
• Responsible for the issuance and tracking of lab notebooks
• Works independently or with others to support quality systems
• Able to react to change productively and handle other essential tasks as assigned

LEADERSHIP & BUDGET RESPONSIBILITIES

Provides guidance and leadership where appropriate.

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.

• Knowledge of cGMP’s and Corden Quality SOP’s and Guidelines as they apply to documentation protocol and validation activities
• Knowledge of process protocols, batch record requirements, and deviation reporting adequacy
• Ability to apply attention to detail, regulatory requirements; and a practical, defendable, logical approach to problem solving
• Knowledge of documentation systems from an auditing technique standpoint

EDUCATION and/or EXPERIENCE

High school diploma or General Education Degree (GED) and 2 years related experience in a Quality Assurance role; or equivalent combination of education and experience. An understanding of chemical concepts and cGMP Manufacturing preferred.

LANGUAGE SKILLS

Ability to read and comprehend instructions, communications, and the general intent of regulatory documentation. Ability to write instructions, communications, and general procedures. Ability to effectively communicate information in one-on-one and small group situations to Quality Department customers and vendors, regulatory authorities, and other employees of the organization. Ability to respond to common inquiries or complaints from customers, regulatory agencies, top management, and peers. 

MATHEMATICAL SKILLS

Ability to add, subtract, multiply, and divide in all units of measure, using whole numbers, common fractions, and decimals. Ability to compute rate, ratio, and percent; and to draw and interpret bar graphs.

REASONING ABILITY

Ability to comprehend and carry out instructions furnished in written, oral, or diagram form. Ability to define problems, collect data, establish facts, and draw valid conclusions. Ability to identify and address interpersonal issues in a professional business manner.

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 regularly required to sit; works with hands; and talk or hear. The employee is occasionally required to stand; walk; reach above shoulder height; climb or balance; stoop, kneel, crouch, or crawl; and taste or smell. The employee must occasionally lift and/or move up to 25 pounds. Specific vision abilities required by this job include 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 moving mechanical parts, fumes or airborne particles and noise typical of an office environment. 

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.

• Flexibility to organize and prioritize workload
• Good customer service skills, as well as effective interpersonal and conflict resolution skills
• Effective writing and editing skills; attention to detail is a must
• Proficiency in file and data organization and management
• Familiarity with manufacturing and regulatory issues pertinent to the pharmaceutical industry; particularly document control procedures

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 Maternity/Paternity Leave
• Tuition Reimbursement
• Wellness Program
• Vacation – Three Weeks 1st Year
• Vision Insurance