Job Description
Within this role, you will perform testing to ensure cGMP compliance in the manufacturing facility. Responsible for assessing the microbiological quality of products, manufacturing equipment, manufacturing process areas, and facility utilities.
This is a shift-based role (12/7 extended days) requiring independent or team work, strong trouble-shooting and problem-solving skills, attention to detail, and excellent written and oral communication skills.
Key Responsibilities:
* Entering laboratory clean-rooms to collect and log samples for microbial analysis.
* Performing bioburden and endotoxin sample analysis in line with standard operating procedures (SOPs).
* Performing sample analysis for microbial identification.
* Performing environmental monitoring, including surface, settling, and viable and non-viable particulate air monitoring of aseptic operations and controlled areas.
* Performing acceptance testing of commercially prepared microbiological culture media.
* Autoclaving microbiological media and laboratory waste as needed.
* Ensuring all work is carried out in compliance with regulatory standards, company policies, and SOPs.
* Completing test records on time and peer reviewing data from other analysts for accuracy and completeness.
* Assisting in the design and setup of the QC microbiology laboratory and selecting, implementing, and calibrating laboratory instruments.
* Participating in microbiological validations for drug substances, in-process controls, buffers, and clean utilities qualification programs.
* Assisting manufacturing personnel in identifying microbiological root causes and providing technical advice as needed.
* Participating in the transfer of methodologies from other test facilities.
* Maintaining laboratory reagents, media, and supplies.
* Conducting laboratory investigations and generating reports in response to invalid assays, deviations, OOS/OOT.
* Initiating and completing CAPAs and change controls in adherence with site procedures.
* Communicating analytical data reports clearly and concisely to management.
* Identifying and implementing lab process improvements and lean initiatives.
Requirements:
* A BS/BA or equivalent experience in Microbiology or related field.
* 2+ years of validated experience, or equivalent combination of education and experience.
About Us:
We are an inclusive and diverse culture that provides comprehensive benefits, which often include health and wellness programs, fitness centers, equity awards, annual bonuses, and paid time off for eligible employees at all levels.
We are an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion or belief (or lack thereof), sex, nationality, national or ethnic origin, civil status, age, citizenship status, membership of the Traveler community, sexual orientation, disability, genetic information, familial status, marital or registered civil partnership status, pregnancy or parental status, gender identity, gender reassignment, military or veteran status, or any other protected characteristic in accordance with applicable laws and regulations.