What are the responsibilities and job description for the QC Associate I Microbiology position at SPECTRAFORCE?
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 :
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 :
Experience of working in a fast-paced team environment, time management, and meet 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.
Quantitatives Dimensions :
This position interacts with QC, QA and Manufacturing personnel and management.
Required Qualifications :
BS degree with 0-3 years in Biology, Microbiology, or life science-related discipline.
Knowledge of GMP, SOP’s and quality control process.
Ability / Flexibility to work evenings and weekends is required
Preferred :
Experience in the pharma / biotech or a GMP healthcare industry.
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