Sr. Quality Assurance Specialist/Quality Assurance Manager
Apply NowCompany: BPS Bioscience, Inc.
Location: San Diego, CA 92154
Description:
About BPS Bioscience
BPS Bioscience is a leading provider of recombinant proteins, assay kits, and cell lines, specializing in supporting drug discovery across various research areas, including cancer, neurology, immunotherapy, epigenetics, and more. We are dedicated to advancing scientific discovery by offering high-quality products and services to researchers worldwide.
The Senior QA Specialist/QA Manager will oversee the Quality Management System (QMS) and associated processes, ensuring quality standards are integrated into the product lifecycle. This role involves developing and enforcing quality standards and procedures, monitoring key quality metrics, and collaborating closely with product development, product management, manufacturing, quality control, and operations teams. Additionally, the Senior QA Specialist/QA Manager will oversee and ensure compliance with ISO 9001:2015 standards. This is an individual contributor role reporting to the Vice President of Quality.
Responsibilities:
Manage the QMS and associated processes in the development, implementation, and execution of quality assurance strategies.
Develop and enforce quality standards and procedures, ensuring all team members follow the established processes.
Monitor and analyze key quality metrics to track product performance and identify areas for improvement.
Work closely with product development, product management, manufacturing, quality control, and operations teams to ensure quality standards are integrated into the product lifecycle. Collaborate closely with customer support teams to gather feedback and improve product quality.
Establish and maintain strong communication channels with other departments to ensure quality expectations are met throughout the production process.
Oversee the planning and execution of audits, inspections, and tests to evaluate product quality.
Conduct root cause analysis of quality issues and implement corrective actions to prevent recurrence.
Ensure compliance with regulatory standards, industry best practices, ISO 9001:2015, and company policies regarding quality assurance processes.
Ensure all product releases meet defined quality criteria before they are launched to customers. Perform tactical batch disposition activities in support of lot release.
Stay updated on industry trends, new quality management methodologies, and regulatory changes that affect product quality.
Review and approve master batch records, deviations, change controls, NCRs, CAPAs, CAPA-EVs, and Product Complaints.
Provide data for monthly and Annual Quality Product Review.
Support audits/inspections (e.g., prepare topics to be presented during inspections). Support management and ensure inspection readiness (e.g., prepare playbooks, participate in mock inspections).
Identify and mitigate risks associated with critical suppliers and supplier quality.
Requirements:
Bachelor's degree in science or related field with 7+ years or equivalent job-related experience of 10+ years in a reagent development and manufacturing Biotech company will be considered for the role.
8+ years of relevant experience in ISO-9001:2015 and ISO-13485:2016 and FDA QSR 21 CFR 820 required. Skilled in using risk-based decision-making approaches.
A minimum of 8 years' experience with reagent testing (e.g., tech transfers, manufacturing and QC testing, stability studies, lab investigations, in-process testing, release testing, PDP, change control) required.
Proven experience managing QMS and associated processes. In-depth knowledge of quality assurance methodologies, tools, and frameworks. Experience managing compliance as it pertains to ISO 9001:2015 including NCRs, CAPAs, and CAPA-EVs required.
Strong leadership, analytical, and problem-solving abilities with attention to detail. Ability to facilitate and influence senior stakeholders and balance workload and timelines.
A record of collaborating and communicating with others and the ability to balance divergent inputs from various partners while driving issues to resolution. Demonstrated ability to lead cross-functional teams, consistently deliver timely and quality results.
Excellent communication, organizational skills, and project management skills with the ability to manage multiple priorities simultaneously.
Relevant certification in Quality Management (Six Sigma, ISO 9001, ISTQB) preferred.
Benefits!
BPS Bioscience Inc. is an equal opportunity employer, without regard to race, color, religion, age, gender, sexual orientation, disability, or any other characteristic protected by applicable law.
BPS Bioscience is a leading provider of recombinant proteins, assay kits, and cell lines, specializing in supporting drug discovery across various research areas, including cancer, neurology, immunotherapy, epigenetics, and more. We are dedicated to advancing scientific discovery by offering high-quality products and services to researchers worldwide.
The Senior QA Specialist/QA Manager will oversee the Quality Management System (QMS) and associated processes, ensuring quality standards are integrated into the product lifecycle. This role involves developing and enforcing quality standards and procedures, monitoring key quality metrics, and collaborating closely with product development, product management, manufacturing, quality control, and operations teams. Additionally, the Senior QA Specialist/QA Manager will oversee and ensure compliance with ISO 9001:2015 standards. This is an individual contributor role reporting to the Vice President of Quality.
Responsibilities:
Manage the QMS and associated processes in the development, implementation, and execution of quality assurance strategies.
Develop and enforce quality standards and procedures, ensuring all team members follow the established processes.
Monitor and analyze key quality metrics to track product performance and identify areas for improvement.
Work closely with product development, product management, manufacturing, quality control, and operations teams to ensure quality standards are integrated into the product lifecycle. Collaborate closely with customer support teams to gather feedback and improve product quality.
Establish and maintain strong communication channels with other departments to ensure quality expectations are met throughout the production process.
Oversee the planning and execution of audits, inspections, and tests to evaluate product quality.
Conduct root cause analysis of quality issues and implement corrective actions to prevent recurrence.
Ensure compliance with regulatory standards, industry best practices, ISO 9001:2015, and company policies regarding quality assurance processes.
Ensure all product releases meet defined quality criteria before they are launched to customers. Perform tactical batch disposition activities in support of lot release.
Stay updated on industry trends, new quality management methodologies, and regulatory changes that affect product quality.
Review and approve master batch records, deviations, change controls, NCRs, CAPAs, CAPA-EVs, and Product Complaints.
Provide data for monthly and Annual Quality Product Review.
Support audits/inspections (e.g., prepare topics to be presented during inspections). Support management and ensure inspection readiness (e.g., prepare playbooks, participate in mock inspections).
Identify and mitigate risks associated with critical suppliers and supplier quality.
Requirements:
Bachelor's degree in science or related field with 7+ years or equivalent job-related experience of 10+ years in a reagent development and manufacturing Biotech company will be considered for the role.
8+ years of relevant experience in ISO-9001:2015 and ISO-13485:2016 and FDA QSR 21 CFR 820 required. Skilled in using risk-based decision-making approaches.
A minimum of 8 years' experience with reagent testing (e.g., tech transfers, manufacturing and QC testing, stability studies, lab investigations, in-process testing, release testing, PDP, change control) required.
Proven experience managing QMS and associated processes. In-depth knowledge of quality assurance methodologies, tools, and frameworks. Experience managing compliance as it pertains to ISO 9001:2015 including NCRs, CAPAs, and CAPA-EVs required.
Strong leadership, analytical, and problem-solving abilities with attention to detail. Ability to facilitate and influence senior stakeholders and balance workload and timelines.
A record of collaborating and communicating with others and the ability to balance divergent inputs from various partners while driving issues to resolution. Demonstrated ability to lead cross-functional teams, consistently deliver timely and quality results.
Excellent communication, organizational skills, and project management skills with the ability to manage multiple priorities simultaneously.
Relevant certification in Quality Management (Six Sigma, ISO 9001, ISTQB) preferred.
Benefits!
- 401k with 4% company match
- Medical/Dental/Vision health insurance plans
- Vacation and paid holidays
- Companywide lunches provided quarterly
BPS Bioscience Inc. is an equal opportunity employer, without regard to race, color, religion, age, gender, sexual orientation, disability, or any other characteristic protected by applicable law.