Quality Control Analyst I - Microbiology
Rentschler Biopharma
Summary
The Quality Control Analyst I in Microbiology performs microbiological analysis of in-process, release, and stability samples to support manufacturing. In addition, the QC Analyst may cross-train with the QC Analytical team to support in-process analytical testing.
Job description
Duties and Responsibilities
- In accordance with test method SOP's, perform microbiological analyses including Bioburden, Endotoxin, TOC, Conductivity, Nitrates, Appearance testing, and Media performance
- 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
- Always maintain sample tracking and integrity until analyses are reviewed
- As part of the Microbiology team, perform general lab maintenance. Order supplies as needed, store materials as indicated and discard expired materials as per manufacturer or test method recommendations
- Support internal and external lab audits as required, including representing QC to auditors as needed
Qualifications
- Bachelor's Degree in Microbiology, Biological Sciences or related scientific discipline
- Knowledge of aseptic technique
- Proficient in use of computer systems to collect and record data
- Knowledge of basic chemical and biological safety procedures
- Must be able to read and follow detailed written instructions like Standard Operating Procedures (SOPs) and communicate effectively, in writing and verbally, to staff at all levels of the organization including staff with varying levels of technical and scientific knowledge
Preferred Qualifications
- 1+ years of Quality and/or lab experience
- Quality Control experience in a CGMP manufacturing facility preferred
Working Conditions
- Laboratory environment working with chemical reagents and analytical equipment
- Personal Protective Equipment must be worn as required
- Entry into utilities rooms for water sampling
- Clean Room gowning and scrubs
- Normal office working conditions: computer, phone, files, fax, copier
- Minimum travel required (Less than 10% domestic)
Physical Requirements
- Participation in a holiday and weekend rotation is required
- Frequent lifting up to 25 lbs
- Frequent standing/walking to work in lab environment for extended periods
- Frequent sitting for extended periods to use computer
Requirements
- Bachelor's Degree in Microbiology, Biological Sciences or related scientific discipline
- Knowledge of aseptic technique
- Proficient in use of computer systems to collect and record data
- Knowledge of basic chemical and biological safety procedures
- Must be able to read and follow detailed written instructions like Standard Operating Procedures (SOPs)
- Communicate effectively, in writing and verbally, to staff at all levels of the organization
- 1+ years of Quality and/or lab experience
- Quality Control experience in a CGMP manufacturing facility preferred
Benefits
- Annual discretionary bonus program
- Medical insurance
- 401(k) program
- Personal and professional wellness support
Company overview
Rentschler Biopharma is a leading global Contract Development and Manufacturing Organization (CDMO) specializing in biopharmaceutical services. Founded in 1872 and now in its fifth generation as a family-owned company, Rentschler Biopharma has over 50 years of experience in biopharmaceutical manufacturing. The company operates from two main sites: its headquarters in Laupheim, Germany, and a facility in Milford, Massachusetts, USA. With approximately 1,400 employees, Rentschler Biopharma offers comprehensive full-service solutions for bioprocess development and manufacturing of complex biopharmaceuticals, including analytical development, process development, formulation development, cGMP manufacturing, and regulatory affairs consulting. The company has an impressive track record, having contributed to nearly 25% of FDA-approved biopharmaceuticals in 2023 and serving over 180 clients worldwide since 1997. Rentschler Biopharma specializes in complex molecules, with more than 50% of their modalities being complex proteins including advanced antibody formats and recombinant enzymes. The company is known for its reliability, quality management systems, and operational excellence philosophy that ensures product quality and productivity at every development and manufacturing stage.