Quality Control 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.
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 the Data Review team.
- Review of Laboratory Investigation Reports (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.
- Assist with metrics for trending and reporting as required, stability, and QC analytical data.
- Assist in training new hires and retraining of QC laboratory staff, as needed.
- Assist/mentor QC new hires on cGMP/GDP.
- Provide timely status updates to Management upon request.
- Perform other duties as assigned.
Task and team-oriented, analytical, organized, detail-oriented, self-motivated, and ability to multitask. Exceptional communication and interpersonal skills. Strong knowledge of QC analytical equipment and software required. Able to prioritize workload to meet stringent timelines. Proficient with MS Outlook, Word, Excel, PowerPoint, and other electronic systems.
Qualifications
- B.S. in Chemistry, Biology, Chemical Engineering, or related biological sciences.
- 3+ years in a cGMP analytical laboratory environment.
- Experience with HPLC, PA800, CS2500, SDS Page.
- Experience with 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.
Pay
Base Pay Range: $90,000 - $110,000
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 support our employees’ personal and professional wellness.