Quality Control Analyst II, Release & Stability Testing (3rd Shift - Contract)

Rentschler Biopharma SE; Milford (MA); On-site; USD 53,726 - 63,369; Full time

Job summary

Rentschler Biopharma SE's Milford, MA site is seeking a Quality Control Analyst II for Release and Stability Testing to perform cGMP analytical testing on stability samples and data evaluation. You will ensure testing within predefined windows, adhere to GMP and SOPs, and collaborate with QC and cross-functional teams.

The role requires 3+ years in a cGMP analytical lab, strong data interpretation skills, and proficiency with HPLC/UPLC and Empower software.

Qualifications

• Bachelor's Degree in Life Sciences and 3+ years in a cGMP analytical lab environment.
• Ability to perform analytical testing and data analysis per GMP.
• Excellent time management and communication across diverse groups.

Responsibilities

• Perform analytical testing using HPLC/UPLC/cGE/icIEF instruments following GMP documents.
• Create/revise SOPs, Protocols and Reports.
• Support or lead OOS/OOT investigations, deviations, change controls, corrective actions, and preventive actions.
• Update and track metrics for trending and reporting; stability and QC analytical data.

Skills

Analytical testing

cGMP

Data interpretation

Communication

Education

Bachelor's Degree in Life Sciences

Tools

HPLC/UPLC/icIEF

Empower chromatography software

Job description

locationsMilford, MA, United Statestime typeVollzeitposted onHeute ausgeschriebenjob requisition idJR2768Advancing 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 II, Release and Stability Testing is responsible for the cGMP analytical testing of stability samples and evaluation of data to ensure compliance with analytical methods, stability protocols, client criteria, Good Laboratory Practices (GLP) and Good Manufacturing Practices (cGMP). They work independently with minimal supervision ensuring stability tests are performed promptly within predefined testing windows. The Quality Control Analyst II, Release and Stability Testing, ensures all work performed strictly adheres to cGMP, SOPs, and protocols. They collaborate with QC team members and cross functional teams for timely resolution of quality issues to achieve project goals. They are responsible for identifying and resolving problems of diverse scope in which analysis of data requires evaluation of identifiable factors based on biochemical knowledge and background.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 ResponsibilitiesPerform analytical testing using HPLC/UPLC/cGE/icIEF instruments following GMP documentsCreate/revise SOPs, Protocols and ReportsPractice safe work habits and adhere to safety procedures and guidelinesPerform maintenance and cleaning of laboratory equipmentSME to support or lead activities related to OOS/OOT investigations, deviations, change controls, corrective actions, and preventive actions to correct and eliminate the potential for non-conformancesUpdate and track metrics for trending and reporting; stability and QC analytical dataTask and team-oriented, analytical, organized, detail-oriented, self-motivated and ability to multitaskProficient with MS Outlook, Word, Excel and PowerPoint, and other electronic systemsExceptional communication and interpersonal skillsAssists in training of new hires and retraining of QC laboratory staff, as neededPerforms other duties as assignedQualificationsBachelor's Degree in Life Sciences disciplineMinimum 3+ years’ experience in a cGMP analytical lab environmentMust have the ability and skill to perform the detailed job requirements competently, safely, accurately, and proficientlySelf-starting motivated person who possesses excellent time management, the ability to adapt to change and organizational skillsAble to communicate, receive, and understand information and ideas with diverse groups of people in a collaborative, comprehensible and reasonable mannerAble to use and learn standard office equipment and technology with proficiencyExperience in Empower chromatography softwareWorking ConditionsLaboratory environment working with chemical reagents and analytical equipmentNormal office working conditions: computer, phone, files, fax, copierPersonal Protective Equipment must be worn as requiredMinimum travel requiredWork is to be performed on sitePossible weekend/off hours testing may be requiredPhysical RequirementsFrequent standing/walkingPPE as requiredAble to work upright and stationary and/or standing for typical working hoursAble to lift and move objects up to 25 pounds____________________________________________________________________________Base Pay Range$39/hr - $46/hrDisclosure StatementRentschler 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 salary pay range is subject to change and may be modified at any time.Brauchen Sie Hilfe?Wenn Sie Unterstützung beim Hochladen Ihrer Bewerbung brauchen, wenden Sie sich bitte an unser Recruiting-Team: [e-mail]