Quality Assurance Specialist - Gmp

BioLegend, Inc. (a Revvity Company) develops world-class, cutting-edge antibodies and reagents for biomedical research, manufactured in our state-of-the-art facility in San Diego, CA. Our mission is to accelerate research and discovery by providing the highest quality products at an outstanding value, along with superior customer service and technical support. Our product expertise covers a diverse set of research areas including Immunology, Neuroscience, Cancer, Stem cells, and Cell Biology.

Job Summary

At BioLegend, we are dedicated to commercializing high-quality reagents to support the life science community for legendary discoveries that lead to cure. This position will contribute to improved quality assurance for current and new GMP bioprocessing products. The main GMP bioprocessing products are biologically active recombinant proteins, antibodies, and cell culture media. The main responsibilities include inspection and material releases, process improvements, support document control team, and participation in audits for existing and new GMP bioprocessing products.

In addition, He/She will assist with batch record review, troubleshooting, and contribute ideas to support finished good bottling, labeling, and the release processes. The position also requires working closely with Product Development, Manufacturing, routine QC, and QA teams to establish or modify assay SOPs. Additional responsibilities include generating and presenting data summaries, providing ETAs, and helping train others on protocols, SOPs, and other quality documents.

We are looking for a highly motivated person who loves science and wants to be part of a dynamic and fast-paced team.

Essential Functions

Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

• Participate in departmental projects and other process improvement initiatives
• Ensure that products adheres to the company’s quality standards, procedures, and policies
• Analyze customer grievances/complaints and other non-compliance issues associated with GMP products
• Other projects or responsibilities as may be required.
• Identify the gaps/deficiencies in Quality Systems and make recommendations for improvements
• Participate in and support the facility in internal, customer, and third-party audits per ISO 13485 requirements
• Plan, execute, and oversee detailed recorded inspection and the release of materials/products per quality specifications
• Investigate product quality issues and ensure resolution in accordance with company guidelines and regulatory requirements
• Create and modify SOPs with support from supervisor/manager

iACT Competencies

• Innovate – Be better, keep improving, be more efficient, creative, and be in the forefront of development
• Transform – Adapt, learn, re-invent and change for future development and growth
• Aspire – Have desire, purpose, and ambition challenging ourselves to push the limits and reach new heights
• Collaborate – Foster teamwork, common goals, selflessness, communication and mutual support

Minimum Qualifications – Education and Experience

• Ability to work with associates at all levels of the organization
• Proficiency in Microsoft Word, Excel, PowerPoint, Office 365, and other programs
• Understanding of relevant regulatory standards/requirements
• 2 Years of hands-on experience in biological techniques
• Bachelor’s degree in a scientific discipline (preferably biology or a related field of study)
• Knowledge of concepts, methods, terminologies, and tools of quality assurance
• 1-2 Years of experience in the related company or with related products

Preferred Qualifications – Education and Experience

• General knowledge of Medical device/GMP guidelines
• 0 – 2 Years of experience in biological techniques
• Relevant Quality Assurance training and/or certification
• Effective verbal and written communication, problem-solving-, and decision-making skills
• Strong analytical skills and attention to detail

The base salary range for this full-time position is $62,000 - $94,500. This range reflects the minimum and maximum target for a new hire in this position. The base pay actually offered to the successful candidate will take into account internal equity, work location, and additional factors, including job-related skills, experience, and relevant education or training. Your recruiter can share more about the specific salary range for your preferred location during the hiring process.

Please note that base pay is only one part of our total compensation package and is determined within a range. This range allows for the successful candidate to have an opportunity to progress within the position and develop at our company. This base pay range does not take into account bonuses, equity, or other benefits which may be applicable and are dependent on the level and position offered.

Work Environment & Physical Demands

Office

While performing the duties of this job, the employee regularly works in an office setting. Occasional exposure to a laboratory and warehouse environment.

The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job.

While performing the duties of this job, the employee is regularly required to use hands and fingers to handle, feel, or operate objects, tools or controls, and reach with hands and arms. The employee is frequently required to stand, talk and hear.

Lab

While performing the duties of this job, the employee regularly works in a laboratory environment with occasional data entry on a computer. Occasional exposure to a warehouse environment.

The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job.

While performing the duties of this job, the employee is regularly required to use hands and fingers to handle, feel, or operate objects, tools or controls, and reach with hands and arms. The employee is frequently required to stand, talk and hear.