Rentschler Biopharma · 19 hours ago
Quality Control Analyst II, Microbiology (2nd Shift)
Milford, MA, United States
Full-time
Onsite
Mid Level
3+ years expRentschler Biopharma is a leading contract development and manufacturing organization focused on biopharmaceuticals. The Quality Control Analyst II, Microbiology will perform microbiological analysis of samples to support manufacturing and ensure compliance with regulatory standards.
BiopharmaBiotechnologyManufacturing
Responsibilities
In accordance with test method SOP’s, perform microbiological analyses including Bioburden, Endotoxin, TOC, Conductivity, Nitrates, Appearance testing, Media performance, Growth promotion and Microbial Identifications
Perform analytical tests as needed such as pH, basic spectrophotometric methods such as A280nm and A550nm, and potency testing
Perform environmental monitoring of cleanrooms and water system sampling
Maintain data integrity and ensure compliance with company SOPs and specifications, FDA, Eu. Ph., GLP, GDP, QSR, and CGMP regulations
Investigate, assess, and troubleshoot assay and/or equipment problems
Notify QC Manager immediately when a deviation, an aberrant result, or an OOT/OOS result is discovered; initiate and participate in authoring investigation reports
Support investigations of deviations and prepare exception documents, utilizing problem solving tools as needed
Participate in method qualifications, validations, and transfers
Always maintain sample tracking and integrity until analyses are reviewed
Prepare and complete change control requests using electronic systems
Support Lean principles such as 5S throughout daily work activities
Ensure personal training requirements are met and that training records are current
Ensure analytical equipment is calibrated and well maintained at all times
Perform general lab maintenance; order supplies as needed, store materials as indicated and discard expired materials as per manufacturer or test method recommendations
Qualification
Required
Bachelor's Degree in STEM
3+ years of experience in biopharmaceutical Quality Control in a GMP environment with specific experience in microbiological testing and sampling
Ability to participate in holiday and weekend coverage is required
Demonstrated experience using relevant QC procedures, specifications, regulations and standards
Knowledge and control of lab testing equipment including determining when and what kind of maintenance is needed
Demonstrated competence in use of computer software, including relevant applications such as Microsoft Office and LIMS
Knowledge of CGMPs regulations including GMP practices for method transfer, qualification and validation
Demonstrated understanding of quality systems including change control, deviations and CAPAs
Knowledge of aseptic technique and impact of product and facility contamination; this includes the performance of microbial identifications and relevant investigations to understand the source of contamination and means to prevent or minimize further occurrence
Ability to handle multiple tasks concurrently and complete tasks in a timely manner
Strong written and verbal language skills to effectively read and write SOP's, related lab reports, and communicate technical information to audiences with varying levels of technical knowledge
Proficient in Microsoft Office – Outlook, Word, Excel, PowerPoint
Company
Rentschler Biopharma
Rentschler Biopharma is a leading contract development and manufacturing organization (CDMO) focused exclusively on client projects.
Founded in 2006Laupheim, Baden-Wurttemberg, DEU
1001-5000 employees
H1B Sponsorship
Rentschler Biopharma has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (4)
2024 (1)
2023 (4)
2021 (2)
Funding
Current Stage
Late StageTotal Funding
$1.6M2016-05-18Series A· $1.6M
Leadership Team
Gunnar Voss von Dahlen
CFO
Christiane Bardroff
Chief Operating Officer
Recent News
2026-01-22
GlobeNewswire
2026-01-20
Company data provided by crunchbase