Quality Assurance Specialist - Supplier Quality
$95k - $110kFull-time
Asahi Kasei Bioprocess America, Inc
The Asahi Kasei Group operates with a commitment of creating for tomorrow. Our business sectors, Material, Homes, and Health Care, contribute to the development of society by anticipating the changing needs of those around the world. We look for candidates that offer a fresh perspective and a variety of skills to help us achieve our commitment. Bionova is a rapidly growing, biologics CDMO focused on developing and manufacturing recombinant protein products using mammalian cell culture processes. Our business success is built on bringing together top scientific talent, arming them with the best available tools, and setting them loose in an agile, energized culture focused on solving difficult client problems. Because our success depends on our ability to exceed our clients' expectations, we look for candidates with an innate desire to serve. Adaptability and an interest in transformative action are also common attributes among our team. Bionova became a subsidiary of Asahi Kasei Medical in May 2022, a division of Tokyo-based Asahi Kasei Group. This acquisition has enabled Bionova to greatly accelerate growth of the business, both in capacity of current service offerings and expansion into new service offerings. Company:
Bionova Scientific LLC Job Description: Position Summary: This role is part of the Quality Assurance Compliance team. As a member of the QA team, the role incumbent has GMP Quality experience assessing supplier's compliance and managing the BNS supplier qualification program. The role also supports Bionova Scientific's self-inspection program, as well as management of the client audits and health authority inspections. The position requires a high attention to detail, to be organized in their work, strong written and verbal communication skills and working well independently and in a team environment. Position Responsibilities: • Assessing potential suppliers through thorough reviews of their quality systems, manufacturing processes, and capabilities to ensure they meet required quality standards • Interface with internal and external suppliers/clients to request/obtain required material and supplier documentation, establish quality agreements as applicable, etc. • Negotiating and maintaining quality agreements with suppliers, outlining expectations regarding product specifications, quality control procedures, and reporting requirements. • Perform actions associated with Change Control documents, discrepancy management and supplier investigations • Conducting regular on-site audits at supplier facilities to verify compliance with established Bionova quality requirements, GMP practices, and documented procedures • Identifying potential quality risks associated with suppliers and implementing mitigation strategies to minimize risks to product quality • Maintaining open communication with suppliers, procurement teams, and internal quality departments to address quality concerns and drive continuous improvement • Enforce quality assurance policies and procedures to maintain product quality and compliance. • Investigating and managing discrepancies that may impact product quality, ensuring proper documentation and corrective actions are taken • Compile metrics for presentation to senior management and communicate disposition status in a timely manner • Coordinate the inspection readiness program for Bionova Scientific • Preparing for and supporting regulatory agency audits, client audits and self-inspection Working Conditions: This position requires work in a lab/office setting. The role requires walking, standing, stooping, kneeling, and crouching. The employee must occasionally lift and or move up to 15 pounds independently. Qualifications: • Bachelor of Science degree or equivalent in a scientific field • Minimum of 5 years' GMP Quality Assurance and Quality Systems experience. Experience with ERP systems and eQMS systems is a must • Expertise in data analysis, trend analysis. • Strong understanding of pharmaceutical manufacturing processes and documentation requirement • Excellent written and verbal communication skills to effectively document findings and present technical information • Working knowledge of GMP regulations and guidance (21 CFR 210/211/11, ANNEX 1, ICH, etc.)• Effective organization and planning skills. Demonstrated ability to deal with frequent changes, delays, or unexpected events • Effective interpersonal and communication skills. Communication at all management levels and all staff is required • Proficiency with relevant quality management systems and software Compensation Range: The base compensation range for this role is between $95,000 and $110,000. However, the actual compensation may vary depending on your experience and qualifications. Health Benefits and Program: Bionova offers health benefits at a subsidized rate. Healthcare, Dental, and Vision insurance Life Insurance and Disability Program: 100% covered by Bionova. Retirement Plan (401K) Up to 8% of Employer Match Paid time off up to two weeks 10 days of Holidays and 5 days of Sick Leave. As an equal opportunity employer, Asahi Kasei believes a diverse workforce will provide us with the ability to continuously support the changes in the economy, society, and environment.
Bionova Scientific LLC Job Description: Position Summary: This role is part of the Quality Assurance Compliance team. As a member of the QA team, the role incumbent has GMP Quality experience assessing supplier's compliance and managing the BNS supplier qualification program. The role also supports Bionova Scientific's self-inspection program, as well as management of the client audits and health authority inspections. The position requires a high attention to detail, to be organized in their work, strong written and verbal communication skills and working well independently and in a team environment. Position Responsibilities: • Assessing potential suppliers through thorough reviews of their quality systems, manufacturing processes, and capabilities to ensure they meet required quality standards • Interface with internal and external suppliers/clients to request/obtain required material and supplier documentation, establish quality agreements as applicable, etc. • Negotiating and maintaining quality agreements with suppliers, outlining expectations regarding product specifications, quality control procedures, and reporting requirements. • Perform actions associated with Change Control documents, discrepancy management and supplier investigations • Conducting regular on-site audits at supplier facilities to verify compliance with established Bionova quality requirements, GMP practices, and documented procedures • Identifying potential quality risks associated with suppliers and implementing mitigation strategies to minimize risks to product quality • Maintaining open communication with suppliers, procurement teams, and internal quality departments to address quality concerns and drive continuous improvement • Enforce quality assurance policies and procedures to maintain product quality and compliance. • Investigating and managing discrepancies that may impact product quality, ensuring proper documentation and corrective actions are taken • Compile metrics for presentation to senior management and communicate disposition status in a timely manner • Coordinate the inspection readiness program for Bionova Scientific • Preparing for and supporting regulatory agency audits, client audits and self-inspection Working Conditions: This position requires work in a lab/office setting. The role requires walking, standing, stooping, kneeling, and crouching. The employee must occasionally lift and or move up to 15 pounds independently. Qualifications: • Bachelor of Science degree or equivalent in a scientific field • Minimum of 5 years' GMP Quality Assurance and Quality Systems experience. Experience with ERP systems and eQMS systems is a must • Expertise in data analysis, trend analysis. • Strong understanding of pharmaceutical manufacturing processes and documentation requirement • Excellent written and verbal communication skills to effectively document findings and present technical information • Working knowledge of GMP regulations and guidance (21 CFR 210/211/11, ANNEX 1, ICH, etc.)• Effective organization and planning skills. Demonstrated ability to deal with frequent changes, delays, or unexpected events • Effective interpersonal and communication skills. Communication at all management levels and all staff is required • Proficiency with relevant quality management systems and software Compensation Range: The base compensation range for this role is between $95,000 and $110,000. However, the actual compensation may vary depending on your experience and qualifications. Health Benefits and Program: Bionova offers health benefits at a subsidized rate. Healthcare, Dental, and Vision insurance Life Insurance and Disability Program: 100% covered by Bionova. Retirement Plan (401K) Up to 8% of Employer Match Paid time off up to two weeks 10 days of Holidays and 5 days of Sick Leave. As an equal opportunity employer, Asahi Kasei believes a diverse workforce will provide us with the ability to continuously support the changes in the economy, society, and environment.
Vacancy posted 3 days ago
Similar jobs that could be interesting for youBased on the Quality Assurance Specialist - Supplier Quality in Fremont, CA vacancy
- Bionova Scientific LLC is seeking a QA Compliance professional to support GMP quality assurance, supplier qualification, and internal/external audits. The role emphasizes meticulous documentation, collaboration with suppliers, and improving quality systems. Responsibilities...Suggested
$95k - $110k
Bionova Scientific, Inc. is seeking a Quality Assurance Specialist in Fremont, CA to ensure supplier compliance and maintain quality standards. The role involves assessing suppliers, managing quality agreements, and conducting audits. Candidates should have at least 5...SuggestedFull time- ...Quality Assurance Specialist /Auditor LeanTeq is best-in-class in a very niche part of the semiconductor industry and is looking for quality-... ...Assist with document improvements. Track KPIs and annual supplier and customer surveys. Support upkeep in Quality...SuggestedWork at officeNight shift
EnPro
Milpitas, CA1 day ago $28.75 - $42.73 per hour
...Supplier Quality Engineer Tesla's Supplier Quality Engineering team plays a critical role as voice of Supply Chain within the Factory... ...consists of Supplier Quality Engineers (SQE) and Supplier Quality Assurance (SQA) Technicians who are responsible for ensuring...SuggestedHourly payFull timeTemporary workMonday to FridayFlexible hoursShift workTesla
Fremont, CA6 hours ago$89.3k - $146.9k
...Summary: Engages in planned and systematic activities to provide confidence that requirements for quality and quality improvement are being met. The Quality Assurance Specialist recommends revisions to, or creation of, new protocols, policies, procedures and/or systems as...SuggestedFull timeTemporary workWork experience placementInternshipWork at officeWorldwideFlexible hoursBio-Techne
Newark, CA7 days ago- Regal Rexnord is seeking a Quality Manager to join the Fremont team. The role focuses on developing and maintaining quality systems, procedures... ...while collaborating with internal teams, customers, and suppliers to resolve issues quickly. Candidates should have 5+ years in...
$36 - $48 per hour
## QA Specialist - Full Time & TemporaryApplyremote type: On-sitelocations: Fremont, CAtime... ...:**The **QA Specialist** will provide Quality Assurance for Quality Control and Analytical... ...Support cGMP compliance audits of GMP suppliers’ quality systems* Support Document Control...Full timeTemporary workWork at office- Scorpion Therapeutics is seeking an experienced QA professional to review analytical quality documentation supporting regulatory submissions and batch dispositions. The role emphasizes GMP compliance, method validation oversight, and collaboration with CMOs and laboratories...
- LeanTeq 濂達科技 in Milpitas, California, is seeking a dedicated Quality Assurance Specialist. The role focuses on ensuring compliance with quality standards like ISO 9001:2015 and ISO/IEC 17025:2017, driving process improvements, and conducting audits. Ideal candidates will...
- Responsibilities Review and approve analytical quality documentation supporting regulatory submissions (INDs, NDAs, amendments, supplements, annual reports). Review and approve batch-related analytical documentation and support product disposition for clinical, registration...Contract workFlexible hours
- Protagonist Therapeutics is seeking a Specialist/Sr. Specialist, Quality Assurance to perform GMP QA activities supporting manufacturing. The role reports to the Head of QA and prioritizes QA GMP support with a risk-based approach, including batch record and deviation...Work at office
$105k - $125k
Revance is seeking a Sr. Specialist, Quality Assurance in Newark, CA for hands-on QA within Quality Systems, focusing on lifecycle management of GxP facilities, instruments, and computerized systems, with collaboration across Quality Control, Manufacturing, IT, Supply Chain...Work at office- The Sr. Document Control Specialist (Temp) at Personalis in Fremont leads daily document control within our Quality Assurance team, applying ISO 13485 and FDA 21 CFR Part 820 standards. This role manages DCOs, EDMS, and cross‑functional reviews with minimal supervision...Temporary workWork at office
- Nova Pneuma, Inc. in Fremont, CA is seeking a strategic VP, Quality & Regulatory Affairs to define and drive global quality and regulatory programs across QA, QC, validation, and supplier quality. This executive role partners with cross-functional leaders to ensure cGMP...
- ...OnsiteStryker is hiring a Senior Staff Clinical Quality Associate for our Neurovascular division... ..., maintain audit schedules, and monitor supplier compliance with quality... ...clinical quality, clinical research, quality assurance, compliance, or a related regulated healthcare...Full timeFor contractors
Stryker
Fremont, CA1 day ago - Bio-Techne is seeking a Sr. Quality Assurance Specialist to ensure quality processes are compliant with ISO 13485 and FDA QSR. You will lead document control, internal audits, CAPA activities, and regulatory reporting while supporting batch record review and material disposition...
- Bionova Scientific LLC in Fremont, CA is seeking a QA Specialist (Full Time) to provide QA for QC and Analytical Laboratories in a fast-paced biotech CDMO. The role focuses on investigations, self-inspection audits, and analytical data review to maintain and expand QC...Full time
- Bio-Techne is seeking a Quality Assurance Specialist to ensure that quality requirements are met and to support continuous improvement. The role involves document control, internal audits, CAPA management, and validation activities to uphold ISO 13485 and FDA Quality System...
$21 - $26 per hour
...Quality Inspector, Nefab Packaging West, Newark, CA Nefab Group is on a growth journey,... ...equivalent to Experience) 2 years in Quality assurance Fluent in English, both written and... ...alerts and provide training) and SCARs (supplier corrective action request). Adhere to ISO...Hourly payLocal areaWorldwideRelocation packageNefab
Newark, CA6 hours ago- ...Supplier Quality EngineerLocation: Fremont, CaliforniaResponsible for supplier quality management of data center rack systems and advanced cooling solutions. The role involves evaluating thermal/mechanical designs, supplier manufacturing capability, reliability test reports...
E-Solutions
Fremont, CA4 days ago - Start your career in quality control with ultimate flexibility! We have immediate openings for quality assurance associates to support production on short-term mandates. This role is perfect for detail-oriented individuals who are comfortable with visual checks and documentation...Hourly payTemporary workWork experience placementLocal areaImmediate startShift work
- Job DescriptionJob DescriptionOn-SEM-Site Supplier Quality Engineer providing a collaborative environment for SEM including: Collaborate with production supervisors and workers for real-time inspection and verification points during processing.Drive closure with AIS stakeholders...
Advantest
Fremont, CAa month ago $40 - $55 per hour
...5.00 per hour Job description: We are seeking an experienced Quality Manager to lead and improve our quality management system in a... ...Perform and support internal audits and customer audits. Manage supplier quality performance and work with vendors to resolve quality...Hourly pay$25 - $26 per hour
...430pm Job Summary We are hiring a Quality Control Technician to inspect materials,... ...isolate bad product and support customer/supplier quality fixes. Follow Standards:... ...assigned. Skills Inspection Quality Assurance Quality Control Measuring (1 year...Hourly payPermanent employmentFull timeTemporary workWork experience placementLocal areaMonday to FridayShift workNewark, CA23 days ago- SoundThinking is seeking a detail-oriented Collection Specialist to rigorously test the performance of our systems. This role requires travel up to 90% and hands-on data collection at customer locations. Hybrid workplace with onsite expectations for locations including...
- Lam Research Corporation seeks a Supplier Engineering Sr. Manager to lead technical efforts in gas integration and OEM components, coordinating... ...across global suppliers and product groups. You will drive quality improvements, RCA, and action tracking while managing complex...
- ...Systems in Fremont, California, is seeking a Quality Manager to develop and maintain the Quality Management... ...compliance. The role involves leading quality assurance activities, driving continuous improvement, and managing supplier quality performance. An ideal candidate will...
$20 per hour
...make healthcare better. Opportunities Available As an RA/QA Quality Assurance intern at Stryker, you will gain hands‑on experience... ...teams such as Manufacturing, Engineering, Regulatory Affairs, Supplier Quality, and Operations to support quality initiatives Review...Hourly payInternshipSummer internshipLive outWork at officeRelocation package$130k - $150k
...designated Regal Rexnord office. Position Overview We are seeking a Quality Manager to join our Fremont team. The ideal candidate brings a... ..., while working closely with internal teams, customers, and suppliers to quickly and effectively resolve issues. You’ll play a key...Permanent employmentWork at officeWorldwide$22 - $24 per hour
...Assists in remedying complex malfunctions, helps to execute product quality inspection activities within the project scope. Works with... ...the company’s main facilities, generally at the customers’ or suppliers’ locations. For this project, you’ll be contracted via a Randstad...Hourly payFull timeTemporary workFor contractorsWork at office3 days per week
Do you want to receive more vacancies?
Subscribe and receive similar vacancies to Quality Assurance Specialist - Supplier Quality. Be the first to apply!
Related searches