Company Information
You Matter to Cambrex.
Cambrex is a leading global contract development and manufacturing organization (CDMO) that provides drug substance, drug product, and analytical services across the entire drug lifecycle. With more than 40 years of experience and a growing team of over 2,000 professionals servicing global clients. Cambrex is a trusted partner in branded and generic markets for API and dosage form development and manufacturing.
Your Work Matters.
At Cambrex, we strive to build a culture where all colleagues have the opportunity to:
engage in work that matters to our customers and the patients they serve
learn new skills and enjoy new experiences in an engaging and safe environment
strengthen connections with coworkers and the community
We're committed to attracting and nurturing a passionate team of valued professionals in our fast-paced and growing company. We offer a competitive benefits package that includes healthcare, life insurance, planning for retirement, and more!
Your Future Matters.
Known for our customer-focused scientific and manufacturing excellence, as well as our strong commitment to quality and safety, we offer a range of career and growth opportunities across our global network of locations. Together with our customers, we aim to improve the quality of life for patients around the world. Start a career where You Matter by applying today!
Job Overview
The Manufacturing Operator II will properly operate solid dose manufacturing equipment to perform production of drug products. Personnel in this position will operate manufacturing processing equipment by following standard operations procedures and batch records in accordance with FDA cGMPs. The main focus for personnel in this position will be responsible to operate, set-up and break down production equipment, clean production areas and maintain consumable supplies.
Responsibilities
Properly operates, sets-up and breaks-down production equipment.
Maintains cGMP suites readiness for manufacturing activities including consumable allocation, cleaning of work area and tools and equipment disinfection.
Performs minor mechanical maintenance of equipment.
Maintains consumable supply inventory.
Washes small utensils and glassware for department.
Properly performs drug product manufacturing, packaging and labeling activities under direct supervision.
Follows written procedures.
Distributes clinical supplies.
Clearly and accurately documents activities for production records and manufacturing equipment (production notebooks, cleaning logs, maintenance logs, etc)
Perform basic math calculations.
Assists with batch records for cGMP manufacturing under direct supervision.
Other duties as assigned.
Qualifications/Skills
Mechanical aptitude is preferred
Moderate knowledge of manufacturing equipment for cGMP environment
Ability to wear Personal Protective Equipment (PPE). Understands and follows safety procedures and works in a manner to avoid injury to self and co-workers. Willingness to work with highly toxic and controlled substances.
Ability to conduct routine in-process testing and visual inspections and identify out-of-specification conditions.
Ability to work in a regulated environment (FDA/DEO/OSHA) and strictly follow procedures.
Effectively communicates both verbally and in writing. Ability to read and comprehend detailed written instructions.
Ability to clearly and concisely document al work activities in a timely manner utilizing existing forms and records. Writes legibly.
Perform basic math functions to include product accountability and material adjustment calculations and rounding. Basic computer skills.
Ability to move materials throughout facility using appropriate methods and equipment.
Operate machinery and read process control instruments to ensure proper operation. Identify operations problems when they occur.
Ability to clean rooms, equipment and tools for use in a cGMP environment.
Perform basic troubleshooting applications.
Provide basic training to other operators after learning a skill set.
Minimal interaction. On an as needed basis.
Exhibited leadership skill in individual area of expertise.
Must have the ability to work overtime when required.
Must adhere to attendance policy of Avista. Expected to arrive for shift on time and contact management immediately if unable to attend work for any period of time.
May directly interact with auditors during a scheduled inspection.
Ability to work effectively within a team environment.
Education, Experience & Licensing Requirements
High school diploma or equivalent with 3+ years of experience in a regulated environment.
The hiring range in Colorado for this position is $35.46/hr. -$39.70/hr.; however, base pay offered may vary depending on job-related knowledge, education, skills and experience of the applicant, internal equity and alignment with market data. This hiring range encompasses several levels. This information is provided per the Colorado Equal Pay Act. This position includes a competitive benefits package.
Cambrex is an Equal Opportunity / Affirmative Action employer and will consider all qualified applicants for employment without regard to race, color, religion, gender, sexual orientation, gender identity, national origin, age, protected veteran status, or disability status.
Supervision Received: Works under limited supervision.
Physical Demands, Work Environment, and Travel
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 use hands to finger, handle, or feel; reach with hands and arms; talk or hear and smell. The employee is frequently required to sit. The employee is occasionally required to stand; walk and stoop. The employee must be able to regularly lift and/or move up to 10 pounds, and occasionally lift and/or move up to 25 pounds. Specific vision abilities required.
Environment and Protective Equipment 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 and vibration. The noise level in the work environment is usually very quiet.
Travel: Little to no expected travel time.
Cambrex is committed to providing a safe and productive work environment. All offers of employment are contingent on the successful completion of a comprehensive pre-employment screen. The pre-employment screen may consist of several components including but not limited to a drug test, criminal record check, identity verification, reference checks, education and employment verification, and may vary based on federal, state, and local laws. Refusal to submit to testing will result in disqualification of further employment consideration.
All requirements are subject to possible modifications to reasonably accommodate individuals with disabilities. Cambrex Corporation is an Equal Opportunity / Affirmative Action employer and will consider all qualified applicants for employment without regard to race, color, religion, sex (including pregnancy, sexual orientation, or gender identity), ancestry, national origin, place of birth, age, marital status, disability/handicap, genetic information, veteran status, or other characteristics protected by federal, state, and/or local law.
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