QC Associate I Microbiology

SPECTRAFORCE; Marlborough (MA); On-site; Full time

Job summary

An established industry player in pharmaceutical manufacturing is seeking a QC Associate I specializing in microbiology. In this role, you will conduct essential microbiological testing and ensure compliance with quality standards in cleanroom environments. Your responsibilities will include performing environmental monitoring tests, supporting cleanroom qualifications, and maintaining laboratory organization. This position offers an exciting opportunity to work in a dynamic team, where your contributions will directly impact the quality of products in the pharmaceutical sector. If you are detail-oriented and passionate about science, this role is perfect for you.

Qualifications

• 0-3 years’ relevant GMP/pharma/microbiology laboratory experience.
• Good knowledge of microbiological testing and aseptic technique.

Responsibilities

• Perform Quality Control Microbiological testing of Environmental Monitoring.
• Support cleanroom qualification and personnel monitoring for manufacturing.

Skills

Aseptic technique

Microbiological testing

Attention to detail

Interpersonal skills

Education

Bachelor’s Degree in biology

Bachelor’s Degree in microbiology

Job description

This range is provided by SPECTRAFORCE. Your actual pay will be based on your skills and experience — talk with your recruiter to learn more.

Base pay range

$30.00/hr - $33.00/hr

Job Title: QC Associate I- Microbiology

Job Location: Marlborough, MA 01752

Job Duration: 6+ Months

Job Responsibilities:

• Perform Quality Control Microbiological testing of Environmental Monitoring (EM) - for viable air, non-viable particulates, surface viable monitoring in manufacturing areas/cleanrooms.
• Perform testing for gram staining, microbial identification, Media growth promotion, endotoxin testing, plate reading, and documentation.
• Support cleanroom qualification, gowning qualification, aseptic process qualification and personnel monitoring for manufacturing activities.
• Receive samples for analysis, ship samples for contract lab testing, enter/review data, and organize data according to cGDP/GMP requirements.
• Revise SOPs/forms, Initiate incident reports and deviations for OOS results -support root cause analysis for EM excursions.
• Assist in EM data review for trending and other technical documentation or projects.
• Perform lab set up, housekeeping/routine cleaning, schedule equipment for preventative maintenance, and organization of laboratory areas in accordance to cGLP/GMP.

Required Qualifications:

• Bachelor’s Degree in biology, microbiology or related life science with 0-3 years’ relevant GMP/pharma/microbiology laboratory experience.
• Ability/Flexibility to work evenings and weekends/holidays is required- to support manufacturing operations.
• Good knowledge of Aseptic technique and common microbiological testing.
• Knowledge of relevant compliance and guidance documents, documentation (ALCOA +) and data organization.
• Must be able to gown into cleanrooms in support of testing and manufacturing activities.
• Detail oriented, willingness to learn and follow instructions.
• Interpersonal skills and ability to contribute to the success of a team.

Preferred Qualifications:

• Experience of working in a fast-paced team environment, time management, and meeting deadlines.
• Team player with the ability and willingness to support other colleagues in the Quality Control department.
• Models our Core Values: Be Bold, Care Deeply, #GetStuffDone – is experienced as someone who exemplifies the culture we want to create; operates with transparency; is trusted.
• Organization and completion of assay documentation and entering data into QC database.
• Write, revise and review Standard Operating Procedures and Forms.
• Lab maintenance and updates on equipment calibrations and equipment use logbooks according to cGMP standards.
• Assist in conducting and documenting laboratory investigations.
• Participates in facility start-up, commissioning, and validation activities.
• Ensures equipment operational readiness and assist with troubleshooting in case of equipment failure.
• Perform other lab duties as required.

Quantitative Dimensions:

• This position interacts with QC, QA and Manufacturing personnel and management.

Seniority Level: Not Applicable

Employment Type: Full-time

Job Function: Science

Industries: Pharmaceutical Manufacturing and Medical Equipment Manufacturing