What are the responsibilities and job description for the QA Warehouse Associate position at CORDEN PHARMA BOULDER INC?
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 support and oversight of Corden Pharma Warehouse activities. 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. Quality Assurance liaison to the warehouse. This position is Monday through Friday, with the possibility of on-call work.
ESSENTIAL DUTIES AND RESPONSIBILITIES
Include the following. Other duties may be assigned
- Oversee current Good Manufacturing Practices related to warehouse activities
- Works directly with warehouse staff to review and correct executed warehouse documentation
- Oversee QA Warehouse activities, including storage of materials and shipping/receiving
- Develop training materials for warehouse staff and conduct training with the applicable staff
- Provides support to QA Management, including compiling and communication of KPIs
- Issue status labels for raw materials and intermediates
- Work 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 GDP and cGMPs as they apply to documentation and data review
- Ability to apply attention to detail, regulatory requirements, and a practical, defendable, logical approach to problem solving
- Excellent technological literacy and ability to navigate multiple platforms (i.e., Microsoft Office, Laboratory Information Management, SAP, and Building Management System Software)
EDUCATION and/or EXPERIENCE
High School Diploma or General Education Degree (GED) and 3 years related experience in the Pharmaceutical industry; 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, noise typical of an office and manufacturing environment, and occasional outdoor tasks.
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; the 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
- Ability to work on 12 hour rotating shifts, night or day; weekends, and holidays required
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
