Quality Control Analyst III, Raw Materials

Rentschler Biopharma • Milford, MA

4d • Onsite

About The Position

Rentschler Biopharma SE is a leading contract development and manufacturing organization (CDMO) focused exclusively on client projects, offering customized full-service solutions for bioprocess development and the production of complex biopharmaceuticals. The company has approximately 1,400 employees and is headquartered in Laupheim, Germany, with a site in Milford, MA, USA. In 2024, Rentschler Biopharma joined the United Nations Global Compact, underlining its commitment to sustainability. The company fosters an open, respectful working environment characterized by quality awareness, diligence, and responsibility, all working towards the vision of advancing medicine to save lives.
The Quality Control Analyst III, Raw Materials, conducts inspection, sampling, and testing of all raw materials and components used in the manufacturing process, adhering to Good Laboratory Practices (GLP) and Good Manufacturing Practices (cGMP). This role works independently with minimal supervision, ensuring stability tests are performed promptly within predefined testing windows. The analyst ensures all work strictly adheres to cGMP, SOPs, and protocols, and collaborates 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 where data analysis requires evaluation of identifiable factors based on biochemical knowledge and background.

Requirements

• Bachelor's Degree in Life Sciences discipline
• Minimum 5+ years’ experience in a cGMP analytical lab environment
• Must have the ability and skill to perform the detailed job requirements competently, safely, accurately, and proficiently
• Self-starting motivated person who possesses excellent time management, the ability to adapt to change and organizational skills
• Able to communicate, receive, and understand information and ideas with diverse groups of people in a collaborative, comprehensible and reasonable manner
• Able to use and learn standard office equipment and technology with proficiency
• Task and team-oriented, analytical, organized, detail-oriented, self-motivated and ability to multitask
• Proficient with MS Outlook, Word, Excel and PowerPoint, and other electronic systems
• Exceptional communication and interpersonal skills

Responsibilities

• Perform compendial testing from USP and Ph. Eur on incoming raw materials
• Perform testing of raw materials, initial, in-process and final products. Parameters include appearance, pH, conductivity, and osmolality
• Work under minimum supervision
• Create/revise SOPs, Protocols and Reports
• Verification of data entry completed by others
• Assists with stability studies as needed and directed. Including removal of samples from stability chambers, aseptic aliquotation, labeling, and verification of samples
• Practice safe work habits and adhere to safety procedures and guidelines
• Perform maintenance and cleaning of laboratory equipment
• SME 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-conformances
• Update and track metrics for trending and reporting; stability and QC analytical data
• Initiate SOP changes to streamline, standardize, and improve quality system processes
• Assists in training of new hires and retraining of QC laboratory staff, as needed
• Performs other duties as assigned

Benefits

• annual discretionary bonus program
• medical insurance
• generous 401K program
• a host of other benefits to aligned to support our employees’ personal and professional wellness

What This Job Offers

• Job Type: Full-time
• Career Level: Senior
• Number of Employees: 251-500 employees