Quality Control Analyst III, Raw Materials

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 III, Raw Materials, conduct inspection, sampling, and testing of all raw materials and components used in the manufacturing process, 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 III, Raw Materials, 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.

Duties And 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.
• 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.
• Assists in training of new hires and retraining of QC laboratory staff, as needed.
• Performs other duties as assigned.
  
  
  

Qualifications

• 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
  
  
  

Working Conditions

• Laboratory environment working with chemical reagents and analytical equipment
• Normal office working conditions: computer, phone, files, fax, copier.
• Personal Protective Equipment must be worn as required
• Minimum travel required.
• Work is to be performed on site
• Possible weekend/off hours testing may be required
  
  
  

Physical Requirements

• Frequent standing/walking
• PPE as required
• Able to work upright and stationary and/or standing for typical working hours
• Able to lift and move objects up to 25 pounds
  
  
  

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Base Pay Range

$90,000 - $110,000

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.