Quality Control Data Reviewer

Data Reviewer

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.

As part of the Milford site's Quality Control team, the Data Reviewer is responsible for the cGMP analytical data review and documentation generated during laboratory analysis in the quality control laboratory. Data review may consist of all/some of the following:

• Review and approval of QC test analytics; in process, release, stability, validation
• Track, organize, prepare QC test results for product release
• Review and approval of LIMS test results, labels and stage reports
• Revise SOPs, Forms
• Train employees on cGMP/GDP

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

Base Pay Range

$90,000 - $110,000

Disclosure 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 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.