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Sr. QA Product Specialist

2 months ago

Boulder, United States Corden Pharma Full time

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.

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

Provides Quality Assurance related product leadership as it relates to planning and execution of customer projects. Responsible for the collaboration, review, and approval of GMP documents needed for products. Represents the highest level of GMP understanding and accomplishment and demonstrated technical knowledge as it relates to cGMP Operations. Responsible for providing strong Quality leadership and scientific/GMP information support as the Quality representative supporting the lifecycle of products for internal and external customers.

ESSENTIAL DUTIES AND RESPONSIBILITIES

Include the following. Other duties may be assigned.

  • Represents QA for all Quality related customer interactions for one or more products. Responsible for clear, direct, and appropriate communication in customer interactions
  • Provides process support including process validation, technical transfer, and commercial activities. May include clinical development as needed
  • Collaborate, review, and approve product-related Change Controls, Master Batch Records, Validation Protocols and Reports, Quality Risk Assessments, Annual Product Quality Reviews, and other cGMP documentation
  • Collaborate, review, and approve minor, major, and critical investigations and Corrective Actions Preventative Actions (CAPAs)
  • Create, report, and communicate quality metrics to internal and external stakeholders
  • Assure that manufacturing processes, packaging, and testing comply with all regulatory filings and Corden SOPs, to ensure favorable quality inspections and customer satisfaction
  • Provides Quality leadership and decision-making on cross-functional teams that include, but are not limited to, Operations, Process Engineering, Quality Control, and Safety
  • Perform final product batch disposition
  • Assist in and represent Quality during internal and external audits and regulatory inspections. May lead audits and inspections as needed
  • Lead efforts that support CordenPharma initiatives and improvements. Knowledgeable in Operational Excellence

LEADERSHIP & BUDGET RESPONSIBILITIES

Responsible for providing Quality leadership throughout the lifecycle of a product. Supports training for QA Product Specialists and other quality personnel. May serve as backup to QA Manager of Commercial Products. Carries out leadership responsibilities in accordance with Corden policies and applicable laws.

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 in Science and 8 years of Quality Assurance experience within the Pharmaceutical Industry; or a combination of Pharmaceutical Industry within a Technical/Operations role and academic experience. Experience in a product decision-making is required. Project Management experience, although not required, is beneficial to this position.

LANGUAGE SKILLS

Ability to read, analyze, and interpret common scientific and analytical journals. Ability to respond to common inquiries or complaints from customers, regulatory agencies, or members of the business community. Ability to communicate information to customers and senior management. Ability to effectively present information to top management and public groups.

MATHEMATICAL SKILLS

Ability to apply mathematical operations to such tasks as frequency distribution, determination of test reliability and validity, analysis of variance, correlation techniques, sampling theory, and factor analysis.

REASONING ABILITY

Ability to apply principles of logical or scientific thinking to a wide range of intellectual and practical problems.

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 talk or hear. The employee frequently is required to stand, walk, and sit. The employee is occasionally required to work with hands; 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 50 pounds. Specific visual abilities required by this job include close vision, distance vision, color vision, peripheral 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 frequently exposed to fumes or airborne particles and low levels of toxic or caustic chemicals. The employee is occasionally exposed to moving mechanical parts, outside weather conditions, and risk of electrical shock. 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.

  • Excellent customer service skills
  • Knowledge of cGMP, cGLP, and FDA regulations, as well as internal quality related procedures
  • Practical and theoretical knowledge of the basic principle of validation and their applications
  • Analytical ability and ability to influence
  • Excellent verbal, presentation, and written communication skills
  • Ability to provide leadership in all aspects of QA/development processes
  • Analytical skills with the ability to function in an interactive interdisciplinary team environment
  • Proactive approach to problem solving and resolution

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 Job Posting will Expire on July 31, 2024