CRS Analyst I

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

Our Clean Room Services team is looking for both entry level and veteran Environmental Monitoring Analysts that are passionate about leveraging their talents to provide an outstanding customer experience. If you’re interested in receiving excellent training and working as part of a team of experts with opportunities for growth, you’ll be a great fit in our strong company culture.

As a Cleanroom Services Analyst you will perform environmental monitoring and cleanroom qualifications within controlled environments. You will travel to regional client sites to provide your expertise with equipment, procedures, policies and regulations to ensure that their cleanrooms meet the requirements for safe manufacturing of medical devices, pharmaceuticals and other patient products.

Responsibilities

Expert use of scientific equipment while following policies and procedures

Measure total air particulate, temperature, humidity and differential pressure

Collect viable air and surface samples

Collect purified water samples for testing

Incubate media plates and enumerate any microbial growth

Submit growth for microbial identification per procedure and client instruction

Maintain and prepare equipment in a GMP environment.

Prepare and complete documentation (paper and electronic) per GDP.

Transport equipment and media to client sites within the New England region in company provided vehicles

Familiarization with client cleanroom layouts, sampling plans and contamination control programs

Sterile gowning and staging equipment and media into client cleanrooms for testing

Other duties as assigned

You will work with team members and under the direction of Cleanroom Services management to improve performance and client satisfaction.

Experienced Analysts will also - Perform compressed gas testing - Perform HEPA filter testing – Write risk assessments, sampling plans, investigations, protocols, reports, SOPs and other technical documents – Design and build electronic workflows – Peer review data – Assist with training – Cross-train to support other business functions, which may include : Validations, Metrology, Microbiology, Quality Assurance, Sales Support and Leadership

Qualifications / Skills

Ability to read, analyze, interpret, and follow standard operating procedures, technical procedures, professional journals and governmental regulations to provide advantage to Cambrex opportunities.

Mathematical skills including the ability to analyze scientific and test data, and a basic understanding of statistical analysis.

Ability to effectively present information to internal and external audiences.

Ability to write reports and business correspondences

Actively participate in team and company meetings.

Excellent interpersonal skills, with ability to interact effectively and work efficiently with customers, partners and colleagues at all levels in an organization.

Excellent communication skills : verbal, written and active listening.

Education, Experience & Licensing Requirements

Entry Level Qualifications

Associate’s degree in Microbiology or related field with a minimum of 12 months of working in a clean room environ ment -OR- High School Diploma or equivalent will be considered with a minimum of 24 months of working in a clean room environment

Sterile gowning experience preferred

Maintains a valid driver’s license and has a good driving record.

Expert Level Qualifications

Bachelor’s degree or higher in Microbiology or related field

Minimum of 12 months of sterile gowning experience

Minimum of 12 months of environmental monitoring sampling and testing experience

CETA or NEBB training / certification preferred

All requirements are subject to possible modifications to reasonably accommodate individuals with disabilities.

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.

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Travel :

This role frequently performs work at client sites, so travel (driving a vehicle) to and from client sites is part of the typical workday. Company vans are provided for travel to client sites, most of which are in southern New England. Approximately 10% of assignments are multi-day requiring overnight accommodation.

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 may be required to use hands to finger, handle, or feel and to reach with hands and arms. The employee is required to talk and hear. The employee is frequently required to stand, walk and sit. The employee may be occasionally required to climb or balance. The employee may be required to regularly lift and / or move up to 10 pounds, frequently lift and / or move up to 25 pounds and occasionally lift and / or move up to 50 pounds. Specific vision abilities required by this job include close vision, distance vision, and peripheral vision.

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 may be occasionally exposed to moving mechanical parts, high precarious places and vibration. The noise level in the work environment is usually quiet. The employee may be required to gain access to lab, manufacturing or clinical areas for inspections or work discussions. The employee is required to wear the appropriate personal protective equipment to perform the job duties. Such personal protective equipment may include but is not limited to : safety eyewear, various types of respirators / breathing apparatus, lab coats, gloves, etc.