Clean Room Analyst - Microbiological Environmental Monitoring

NCSL International; Agawam (MA); On-site; USD 34,000 - 48,000; Full time

Job summary

Cambrex is seeking a Clean Room Analyst - Microbiological Environmental Monitoring to join our Environmental Monitoring team in the New England region. You will perform environmental monitoring in cleanrooms, collect samples, and maintain documentation in a GMP setting.

Travel to client sites is required to support testing, and you will collaborate with experienced staff to ensure compliance with regulatory standards.

Qualifications

• Ability to read, analyze, interpret SOPs, procedures and regulations.
• Strong written and verbal communication; capable of reporting and documentation.

Responsibilities

• Perform environmental monitoring and cleanroom qualifications in controlled environments.
• Travel to regional client sites to support testing and sampling.

Skills

SOP reading

Statistical analysis

Communication

Documentation

Team participation

Interpersonal skills

Verbal and written communication

Education

Associate's degree in Microbiology

Bachelor's degree in Microbiology

CETA or NEBB training/certification

Job description

Cambrex

Clean Room Analyst - Microbiological Environmental Monitoring

Regular Full-Time

Openings: 1

Category: Clean Room Services

US-MA-Agawam

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.

Qualifications

Entry Level Qualifications

• Associate's degree in Microbiology or related field with a minimum of 12 months of working in a clean room environment-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
• Employees in this role must be able to obtain and use a company-authorized payment method, such as a company credit card or fleet fuel card, to purchase fuel and other approved business expenses.

The estimated hourly rate range of $25-29/hour reflects an anticipated range for the CRS Analyst I position. The estimated hourly rate range of $27-$32/hour reflects an anticipated range for the CRS Analyst II position The estimated hourly rate range of $30-35/hour reflects an anticipated range for the CRS Analyst III position The actual hourly rate offered may depend on a variety of factors, including the qualifications of the individual applicant for the position, years of relevant experience, specific and unique skills, level of education attained, and certifications or other professional licenses held.The actual hourly rate offered will be in accordance with state or local minimum wage requirements for the job location.

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

Cambrex is an Equal Opportunity / Affinitive 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.