Quality Control Data Reviewer

2 days ago

Milford, MA, United States Rentschler Full time
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
  • Review and approval of cGMP analytical data comparing results to internal and customer specifications, SOPs, and established standards to ensure accuracy and quality of data
  • Works collaboratively with QC team members and cross functional teams for timely resolution of quality issues to achieve project goals
  • Support Product Release activities ensuring timelines are met
  • Work on problems of diverse scope in which analysis of data requires evaluation of identifiable factors
  • Identify and resolve issues with assistance from Data Review team
  • Review of LIRs
  • Support all data integrity initiatives and strive for right first time
  • Make daily decisions about the quality of data based on biochemical knowledge and compliance background
  • Revise, create SOPS and/or test forms as required
  • Assists with metrics for trending and reporting as required, stability and QC analytical data
  • Task and team-oriented, analytical, organized, detail-oriented, self-motivated and ability to multitask
  • Exceptional communication and interpersonal skills
  • Assists in training of new hires and retraining of QC laboratory staff, as needed
  • Assist/mentor QC new hires on cGMP/GDP
  • Strong knowledge of QC analytical equipment and software required
  • Strong communications skills - written and verbal
  • Able to prioritize workload to meet stringent timelines
  • Provide timely status updates to Management upon request
  • Proficient with MS Outlook, Word, Excel and PowerPoint, and other electronic systems
  • Performs other duties as assigned
Qualifications
  • B.S. in Chemistry, Biology, Chemical Engineering, or related biological sciences
  • 3+ years in a cGMP analytical laboratory environment
  • HPLC, PA800, CS2500, SDS Page
  • LIMS, EMPOWER
  • cGMP experience
Working Conditions
  • Personal protective equipment must be worn in the laboratories according to Rentschler safety requirements
  • Will interact with other departments
  • Pace may be fast and job completion demands may be high
  • Not a hybrid position, work must be performed on site
Physical Requirements
  • May be required to stand for long periods of time while performing review of lab logbooks, equipment, lab documentation
  • Must be able to walk distances between labs, offices, departments
  • Must be able to work safely in a lab environment
  • PPE as required

  • Supplier Quality Engineer

    6 days ago

    Milford, MA, United States Life Science Staffing Full time

    Position Summary: The responsibilities of the supplier quality engineer include securing supplies and parts for the assembly line, reviewing engineering and manufacturing specifications, monitoring materials for any defects, and resolving quality issues. Essential Functions: Work with Supplier Quality improvement teams, manage supplier yield/data reporting,...

  • Supplier Quality Engineer

    2 days ago

    Milford, MA, United States Life Science Staffing Full time

    Position Summary: The responsibilities of the supplier quality engineer include securing supplies and parts for the assembly line, reviewing engineering and manufacturing specifications, monitoring materials for any defects, and resolving quality issues. Essential Functions: Work with Supplier Quality improvement teams, manage supplier yield/data reporting,...

  • Quality Manager

    6 days ago

    Milford, MA, United States Consigli Construction Full time

    Employment Type: Full-Time  FSLA:  Salary/Exempt  Division: Field Operations  Department: Quality  Reports to: Regional Quality Manager  Supervisory Duties: No The Quality Manager (QM) will collaborate with several project teams throughout the lifecycle of their assigned projects. Their main responsibility is to support and be a technical and field...

  • Quality Manager

    2 weeks ago

    Milford, MA, United States Consigli Construction Full time

    Employment Type: Full-Time  FSLA:  Salary/Exempt  Division: Field Operations  Department: Quality  Reports to: Regional Quality Manager  Supervisory Duties: No The Quality Manager (QM) will collaborate with several project teams throughout the lifecycle of their assigned projects. Their main responsibility is to support and be a technical and field...

  • Quality Manager

    2 days ago

    Milford, MA, United States Consigli Construction Full time

    Employment Type: Full-Time  FSLA:  Salary/Exempt  Division: Field Operations  Department: Quality  Reports to: Regional Quality Manager  Supervisory Duties: No The Quality Manager (QM) will collaborate with several project teams throughout the lifecycle of their assigned projects. Their main responsibility is to support and be a technical and field...

  • Quality Manager

    1 week ago

    Milford, MA, United States Consigli Construction Full time

    Employment Type: Full-Time  FSLA:  Salary/Exempt  Division: Field Operations  Department: Quality  Reports to: Regional Quality Manager  Supervisory Duties: No The Quality Manager (QM) will collaborate with several project teams throughout the lifecycle of their assigned projects. Their main responsibility is to support and be a technical and field...

  • Operations Quality Manager

    4 days ago

    Milford, MA, United States Waters Full time

    Operations Quality ManagerReq. # 23492Job Family QA - Quality Assurance & ControlLocationUS-MA-MilfordPay Range Minimum USD $106,000.00Pay Range Maximum USD $176,500.00OverviewThe Operations Quality Manager reports to the Regional Quality Director, Americas. Responsibilities of the role include supporting all Quality activities in Milford Assembly and...

  • Senior IT Auditor and Data Analyst

    1 week ago

    Milford, MA, United States Waters Full time

    Senior IT Auditor and Data AnalystReq. # 22146Job Family FI - FinanceLocationUS-MA-MilfordPay Range Minimum USD $81,500.00Pay Range Maximum USD $135,500.00OverviewThe Senior IT and Data Analytics Internal Auditor provides support to the Internal Audit Department by demonstrating analytical and creative thinking that results in the extraction and analysis...

  • Data Integration Architect

    19 hours ago

    Milford, MA, United States Waters Full time

    Data Integration Architect (BD)Req. # 24891Job Family BT - Business TechnologyLocationUS-MA-MilfordPay Range Minimum USD $144,500.00Pay Range Maximum USD $240,500.00OverviewThe Data Integration Architect will oversee and execute the integration of data and systems from a newly acquired acquisition into the enterprise data landscape. This role is critical...

  • Data Integration Architect

    4 days ago

    Milford, MA, United States Waters Full time

    Data Integration Architect (BD)Req. # 24891Job Family BT - Business TechnologyLocationUS-MA-MilfordPay Range Minimum USD $144,500.00Pay Range Maximum USD $240,500.00OverviewThe Data Integration Architect will oversee and execute the integration of data and systems from a newly acquired acquisition into the enterprise data landscape. This role is critical...