Quality Control Analyst I - Microbiology

Rentschler Biopharma, Inc.; Milford (MA); On-site; USD 55,000 - 75,000; Full time

Job summary

Rentschler Biopharma is seeking a Quality Control Analyst I in Microbiology at our Milford, MA site to perform microbiological analyses of process samples and support release testing. You will work to maintain data integrity and ensure adherence to SOPs, FDA and CGMP guidelines.

This role requires a Bachelor’s degree in Microbiology or related field, aseptic technique knowledge, and strong data recording skills.

Qualifications

• Bachelor’s degree in Microbiology or related science field.
• Knowledge of aseptic technique.
• Proficient in using computer systems to collect and record data.
• Knowledge of basic chemical and biological safety procedures.
• Must read and follow detailed written instructions (SOPs) and communicate effectively with staff at all levels.

Responsibilities

• Perform microbiological analyses of in-process, release, and stability samples per SOPs.
• Conduct environmental monitoring of cleanrooms and water sampling.
• Maintain data integrity and ensure compliance with SOPs and regulations (FDA, Eu. Ph., GLP, GDP, QSR, CGMP).
• Maintain sample tracking and integrity until analyses are reviewed.
• Support internal and external lab audits and represent QC to auditors as needed.

Skills

Aseptic technique

Data collection & entry

Safety procedures

Follow SOPs

Education

Bachelor’s Degree in Microbiology

Job description

Advancing medicine to save lives. Together.

Thanks to many decades of experience and our passion for what we do, we make an essential contribution to the global availability of biopharmaceuticals, especially for patients with rare and serious diseases.

Rentschler Biopharma SE is a leading contract development and manufacturing organization (CDMO) focused exclusively on client projects. We offer customized full-service solutions for bioprocess development and the production of complex biopharmaceuticals. As a German family-owned company with an international footprint and global reach, we combine experts, expertise and years of experience to develop best-in-class solutions – together with our clients.

Rentschler Biopharma has approximately 1,400 employees and is headquartered in Laupheim, Germany, with a site in Milford, MA, USA. In 2024, we joined the United Nations Global Compact, underlining our commitment to sustainability.

As an independent family-owned company, we live by the motto: Many hands, many minds - ONE TEAM! Open, respectful cooperation characterizes our working environment, where quality awareness, diligence and responsibility are our top priorities. With all the diversity of our talents in the Rentschler team, we pursue one vision together: advancing medicine to save lives.

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.

Join our QC team with a quality mindset first to help make and release medicines for better lives. Our team is built on trust, respect, and integrity. The quality mindset is about operating with reliability, efficiency, and honest feedback.

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 are 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

Base Pay Range

$XXX,XXX - $XXX,XXX

Disclosure Statement

Rentschler Biopharma, Inc is committed to fair and equitable compensation practices. The base pay range listed for this position is the anticipated annual base salary range the organization reasonably, and in good faith, expects to pay for this position at this time. Actual compensation is determined based on several factors that may include seniority, education, training, relevant experience, relevant certifications, geography of work location, job responsibilities, or other application factors permissible by law. The annual base salary is just one component of our Total Rewards package, which also includes our annual discretionary bonus program, medical insurance, our generous 401K program, plus a host of other benefits to aligned to support our employees’ personal and professional wellness. The salary pay range is subject to change and may be modified at any time.