Senior QC Sample Data Management Specialist

A healthier future. It's what drives us to innovate. To continuously advance science and ensure everyone has access to the healthcare they need today and for generations to come. Creating a world where we all have more time with the people we love. That's what makes us Roche.

The position will be responsible for sample and data management within the QC laboratories. Specifically, the position will perform and coordinate sample receipt/inspection/login/distribution/disposal/shipping, control the chain of custody, and support internal and external testing. This position will be responsible for monitoring and tracking sample status through the sample lifecycle, tracking QC data records from initiation to QC reconciliation, ensure target due dates are met, and provide management updates on project timelines/status. This position will also be the point of contact for cross building support and associated processes. In addition, the position will drive improving the current process and revising SOPs accordingly, lead in deviation investigations, facilitate training, perform laboratory maintenance, perform routine laboratory testing, support equipment maintenance and trend metrics as needed. This role will also provide oversight of the daily activities ongoing in the sample management area.

Specific duties and responsibilities include:

• Sample management; Chain of custody control; Sample shipping management; Controlled document print, distribution, and reconciliation

• Cross-building SDM support and oversite; Maintain regulatory retain and characterization inventories and inspections

• Monitoring and tracking sample lifecycles; Monitoring and tracking data lifecycles; SME for SDM LIMS

• GMP document generation and revision; Leading Sample Management deviations and investigations

• Regulatory and internal audit support; Operational data trending for process improvement; Gathering data required for metrics for Sample Management; Supporting routine laboratory testing

Education and Experience Requirements

• Bachelor's degree in biology, chemistry, or related discipline preferred

• 3 - 6 years of biopharmaceutical working experience, with at least 2 years GMP experience

• Experience with QC sample management and GMP document revision

• Experience with using LIMS to manage samples

• Experience in technical writing

• Experience in regulatory audits as a plus

• Experience with performing testing (e.g. qPCR, ELISA, HPLC, etc.) as a plus

• Experience with reviewing GMP and non-GMP data as a plus

• Lean six sigma training as a plus.

Key Skills, Abilities, and Competencies

• Be able to multitask and work independently in a regulated environment with limited supervision

• Be able to manage time and perform tasks based on the project timelines and requirements

• Familiar with good documentation practice, high attention to details, and good organizational skills

• Knowledge of common QC tests for vector-based product as a plus

• Ability to review and provide feedback on daily operations

• Ability to support as SME in regulatory and internal audits

• Ability to take ownership to a process and drive the improvement, evaluate impact to the current process (including quantifying improvement), and report out clearly to key stakeholders.

• Motivated to assume ownership of protocols, experiments, and continuous improvement projects

• Proficient in Word, PowerPoint and Excel

• Good understanding and application of principles, concepts, practices, standards of GMP requirement

• May need to be available for some weekend or off hour scheduled work

Relocation benefits are not available for this posting

The expected salary range for this position based on the primary location of Philadelphia, PA is $73,500 to $136,500 annually. Actual pay will be determined based on experience, qualifications, geographic location, and other job-related factors permitted by law. A discretionary annual bonus may be available based on individual and Company performance. This position also qualifies for the benefits detailed at the link provided below.

Benefits

Genentech is an equal opportunity employer. It is our policy and practice to employ, promote, and otherwise treat any and all employees and applicants on the basis of merit, qualifications, and competence. The company's policy prohibits unlawful discrimination, including but not limited to, discrimination on the basis of Protected Veteran status, individuals with disabilities status, and consistent with all federal, state, or local laws.

If you have a disability and need an accommodation in relation to the online application process, please contact us by completing this form Accommodations for Applicants.