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Quality Control Analyst II, Raw Material

Quality Control Analyst II, Raw Material

RentschlerMilford, MA, United States
1 day ago
Job type
  • Full-time
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.

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
  • Perform incoming inspection of components used in the manufacturing process
  • Perform sampling of materials to be tested in the raw materials laboratory
  • Perform assays requiring precise analytical skills (i.e. Karl fisher, FTIR, UV Vis)
  • Complete all testing, including special project / protocol testing in a timely and appropriate manner
  • Maintain data integrity and ensure compliance with company SOPs and specifications, FDA, GLP, QSR and cGMP regulations
  • Initiate deviations and laboratory investigations
  • Participate in functions involving teams, which impact production, increase efficiency, solve problems, generate cost savings and improve quality
  • Perform laboratory and manufacturing audits as required. Audit and update, as required, plant SOPs
  • Perform equipment maintenance and calibrations as required

Qualifications

  • Bachelor's Degree in Microbiology, Biological Sciences are related scientific discipline
  • 3+ years of relevant and hands on experience
  • Knowledge of aseptic technique and basic chemical and biological safety procedures
  • Proficient in use of computer systems to collect and record data
  • 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

    • Working Conditions

  • Laboratory environment working with raw materials
  • Personal Protective Equipment must be worn as required
  • Inspection of materials in warehouse
  • Sampling room gowning
  • Normal office working conditions : computer, phone, files, fax, copier
  • Minimum travel required (Less than 10% domestic)
  • Personal Protective Equipment must be worn as required

    • Physical Requirements

  • Participation in a holiday and weekend rotation is required
  • Frequent lifting up to 50 lbs
  • Frequent standing / walking to work in lab environment for extended periods
  • Frequent sitting for extended periods to use computer
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    Quality Control Analyst • Milford, MA, United States