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Manager, Quality Control- Newark, CA- SBD/Bio-Techne

By joining Bio-Techne, you’ll join a company with a powerful and positive purpose of enabling cutting-edge research in Life Sciences and Clinical Diagnostics. Bio-Techne, and all of its brands, provides tools for researchers to further treat and prevent disease worldwide.

Advanced Cell Diagnostics, Inc. (ACD) is a leader in the field of molecular pathology and tissue-based diagnostics. Our core RNAscope® technology is the world’s first multiplex fluorescent and chromogenic in situ hybridization platform capable of detecting and quantifying RNA biomarkers in situ at single molecule sensitivity. RNAscope® is an ideal platform for developing the next generation of tissue-based companion diagnostics. We are committed to continued innovation to bridge the gap between basic research and clinical medicine to fulfill the promise of personalized medicine.

Salary range: $121,000 - $182,000 plus annual bonus package and benefits.

Position Description:

This position is responsible for managing and coordinating the safety, quality, execution, and continuous improvement activities of the Quality Control team (assay manufacturing) for Research Use Only and IVD products by following cGMP processes.

As a people leader for the site, this individual will exhibit strong leadership traits and be perceived by not only their group as a leader, but also by the site when Quality Control issues arise. This will be accomplished by ensuring that key responsibilities are met, and by maintaining a strong Quality culture throughout the QC portions of the facility in cooperation with other departments.

Coordinates, leads, and ensures the successful day-to-day operations of Quality Control departments for the company. This leader ensures the success of the teams by oversight of Supervisor/s of the functional groups and direct management of the individual contributors. The role will partner closely with the manufacturing team to ensure compliances to process and supporting overall site improvements. The role will also support the introduction of new products.

Key Responsibilities:

• Responsible for incoming Quality Control of materials and the functional release testing of finished goods with batch record review and release.

• Provides supervision to Quality Control associates on day-to-day activities of Quality control laboratory, schedule tasks, and monitors completion of assigned tasks. Assists with helping prioritize workload and assigning testing, ensuring effective daily operation of the department.

• Participates in the review of data reports results and completes all required documentation and electronic system entries.

• Accountable for accurate and timely completion of activities related to testing and projects.

• Performs test method validation and transfer to production as required, and active participation on product transfer team projects and NPIs.

• Assists in documentation creation and revising, including test methods, product specifications, SOPs, etc. as required.

• Analyses and drives implementation of improvements related to QC processes and procedures.

• Performs troubleshooting and offers corrective recommendations within the team or/and for customer feedback.

• Responsible for hiring, developing and evaluating department associates.

• Communicates with other group departments such as MFG, R&D, and/or external customers within area of responsibility.

• Maintains working knowledge of current QC standard operating procedures (SOPs}, scientific literature, and new technologies, theories, and principles within area of scientific field.

• Responsible for training staff.

• Ensures that timely, accurate, qualified, and cost-effective testing is performed on: Raw Materials, In-process Materials, Finished Goods and Procured Finished Goods.

• Leads and ensures compliance of the Quality systems assigned: Quality Control System, Quality Inspections and supports Stability Program.

• Perform all job duties within regulatory or statutory requirements.

Qualifications

Qualifications:

• A Bachelor in Life Sciences or Engineering.

• Minimum 8 years of Pharmaceutical / Medical Device experience in Quality Control, including progressive supervisory/managerial experience.

Preferred Qualifications:

• Experience in tissue/cell-based assays (spatial biology) such as immunohistochemistry and in situ hybridization (IHC/ISH), fluorescent microscopy, and imaging.

• Experience in product transfer, laboratory facilities/utilities, and site expansion projects.

• Lean Six Sigma experience required. Certified Six Sigma preferred.

• Solid understanding in all aspects of lab testing/Quality Control and Quality Management Systems.

• Solid understanding of quality system regulations/requirements (ISO: 13485).

• Experience in the following systems: LIMS, ERP, MRP.

• Experience in writing and understand technically related protocols.

Why Join Bio-Techne:

• We offer competitive salaries along with extensive medical, vision, and dental plans for you and your family starting on day one!

• We invest in our employees’ financial futures through 401k matching and an employee stock purchase plan.

• We help our employees develop their careers through mentorship, promotional opportunities, training and development, internship programs, and more.

• We offer employee resource groups, volunteer paid time off, employee events, and charity drives to build a culture of caring and belonging.

• We foster a culture of empowerment and innovation, where employees feel valued and encouraged to bring their new ideas to the table.

All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran.

Bio-Techne is an E-Verify Employer in the United States.