QC Associate, Data Digitalization Job at 10x Genomics (Pleasanton)

Sr. Manager Quality Control - Chemistry

At Amgen, if you feel like you’re part of something bigger, it’s because you are...

Location

United States , Holly Springs

Salary:

142103.85 - 192258.15 USD / Year

Amgen

Expiration Date

Until further notice

Requirements

High school diploma / GED and 12 years of Aseptic Manufacturing experience OR Associate’s degree and 10 years of Aseptic Manufacturing experience OR Bachelor’s degree and 8 years of Aseptic Manufacturing experience OR Master’s degree and 6 years of Aseptic Manufacturing experience OR Doctorate degree and 2 years of Aseptic Manufacturing experience
In addition to meeting at least one of the above requirements, you must have a minimum of 2 years experience directly managing people and/or leadership experience leading teams, projects, programs, or directing the allocation or resources.

Job Responsibility

Lead teams responsible for the QC Chemistry laboratory and 1st and 2nd shift Quality Control operations
Include the startup and validation of laboratory equipment, transfer and implementation of analytical methods, and development of a diverse team to support site startup and successfully transition into steady-state commercial operations at Amgen North Carolina
Overall responsibility for startup, operational readiness, and day-to-day management of the QC Chemistry laboratory and oversight of 1st and 2nd shift QC teams, including successfully transitioning the organization from site startup activities into routine commercial operations
Lead QC Chemistry functions supporting analytical method families including chromatography (HPLC/UPLC), capillary electrophoresis (CE), gel-based methods, and general compendial chemistry testing
Manage 1st and 2nd shift managers 7 days a week for cross functional night shift support for manufacturing
Ensure laboratory and shift operations are conducted in compliance with safety guidelines, cGLPs, cGMPs, and other applicable regulatory requirements
Build, lead, coach, and develop a high-performing organization capable of supporting both startup execution and long-term commercial manufacturing operations
Implement effective digital tools for leading the organization
Partner cross-functionally with Manufacturing, Process Development, Quality Assurance, Facilities & Engineering, Supply Chain, and other site functions to support startup readiness, process performance, and ongoing manufacturing operations
Participate in regulatory agency inspections and support site licensure and inspection readiness activities

What we offer

A comprehensive employee benefits package, including a Retirement and Savings Plan with generous company contributions, group medical, dental and vision coverage, life and disability insurance, and flexible spending accounts
A discretionary annual bonus program, or for field sales representatives, a sales-based incentive plan
Stock-based long-term incentives
Award-winning time-off plans
Flexible work models where possible

Fulltime

Quality Associate III

This is where you make a difference in our patients’ safety. As a member of the ...

Location

United States , Round Lake

Salary:

96000.00 - 132000.00 USD / Year

Baxter

Expiration Date

Until further notice

Requirements

Bachelor's degree in Microbiology, Biology, Chemistry, or a related scientific field with 8+ years of experience in a regulated pharmaceutical or medical device environment, OR Master's degree in a related field with 5+ years of relevant experience
Experience with microbiological testing and environmental monitoring, particularly in regulated settings
Familiarity with investigation processes (e.g., OOS, OOT, or atypical results) and structured problem-solving approaches
Ability to develop and maintain GMP-compliant documentation (e.g., SOPs, test methods, protocols)
Working knowledge of cGMP and regulatory expectations, including data integrity principles
Experience using laboratory systems (e.g., LIMS or similar tools)
Clear communication skills with the ability to present technical information in an understandable way
Strong organizational skills and the ability to manage multiple responsibilities effectively
Experience in sterile manufacturing or contamination control environments
Exposure to regulatory inspections or audits within a microbiology function

Job Responsibility

Support and guide QC Microbiology activities at RLDD, including environmental monitoring, contamination control, and laboratory operations
Contribute to validation and lifecycle activities for microbiological methods, instruments, and laboratory systems, including qualifications, method transfers, and change assessments
Partner with cross-functional teams to evaluate microbiological risks, support issue resolution, and inform product quality decisions
Lead and support investigations (e.g., deviations, atypical results, EM excursions) using structured, science-based approaches to determine root cause and implement effective corrective actions
Prepare and maintain microbiology documentation such as SOPs, test methods, protocols, and contamination control strategy content, ensuring clarity and compliance with regulatory expectations
Perform laboratory assessments and data reviews to identify improvement opportunities and sustain a state of inspection readiness
Support adoption and continuous improvement of laboratory tools and systems (e.g., LIMS, EM systems, data trending tools) to strengthen efficiency and data integrity
Share knowledge and provide guidance to colleagues
contribute to audits and inspections by preparing documentation and responding to microbiology-related inquiries

What we offer

Support for Parents
Continuing Education/ Professional Development
Employee Heath & Well-Being Benefits
Paid Time Off
2 Days a Year to Volunteer
medical and dental coverage starting on day one
basic life, accident, short-term and long-term disability, and business travel accident insurance
Employee Stock Purchase Plan (ESPP)
401(k) Retirement Savings Plan (RSP)
Flexible Spending Accounts

Fulltime

Quality Associate III

As a Quality Associate III – QC Microbiology, you will support microbiological q...

Location

United States of America , Round Lake

Salary:

96000.00 - 132000.00 USD / Year

Baxter

Expiration Date

Until further notice

Requirements

Bachelor's degree in Microbiology, Biology, Chemistry, or a related scientific field with 8+ years of experience in a regulated pharmaceutical or medical device environment, OR Master's degree in a related field with 5+ years of relevant experience
Experience with microbiological testing and environmental monitoring, particularly in regulated settings
Familiarity with investigation processes (e.g., OOS, OOT, or atypical results) and structured problem-solving approaches
Ability to develop and maintain GMP-compliant documentation (e.g., SOPs, test methods, protocols)
Working knowledge of cGMP and regulatory expectations, including data integrity principles
Experience using laboratory systems (e.g., LIMS or similar tools)
Clear communication skills with the ability to present technical information in an understandable way
Strong organizational skills and the ability to manage multiple responsibilities effectively
Experience in sterile manufacturing or contamination control environments
Exposure to regulatory inspections or audits within a microbiology function

Job Responsibility

Support and guide QC Microbiology activities at RLDD, including environmental monitoring, contamination control, and laboratory operations
Contribute to validation and lifecycle activities for microbiological methods, instruments, and laboratory systems, including qualifications, method transfers, and change assessments
Partner with cross-functional teams to evaluate microbiological risks, support issue resolution, and inform product quality decisions
Lead and support investigations (e.g., deviations, atypical results, EM excursions) using structured, science-based approaches to determine root cause and implement effective corrective actions
Prepare and maintain microbiology documentation such as SOPs, test methods, protocols, and contamination control strategy content, ensuring clarity and compliance with regulatory expectations
Perform laboratory assessments and data reviews to identify improvement opportunities and sustain a state of inspection readiness
Support adoption and continuous improvement of laboratory tools and systems (e.g., LIMS, EM systems, data trending tools) to strengthen efficiency and data integrity
Share knowledge and provide guidance to colleagues
contribute to audits and inspections by preparing documentation and responding to microbiology-related inquiries

What we offer

Medical and dental coverage that start on day one
Insurance coverage for basic life, accident, short-term and long-term disability, and business travel accident insurance
Employee Stock Purchase Plan (ESPP), with the ability to purchase company stock at a discount
401(k) Retirement Savings Plan (RSP), with options for employee contributions and company matching
Flexible Spending Accounts
Educational assistance programs
Time-off benefits such as paid holidays, paid time off ranging from 20 to 35 days based on length of service, family and medical leaves of absence, and paid parental leave
Commuting benefits
Employee Discount Program
Employee Assistance Program (EAP)

Fulltime

Quality Associate III

This is where you make a difference in our patients’ safety. As a member of the ...

Location

United States , Round Lake

Salary:

96000.00 - 132000.00 USD / Year

Baxter

Expiration Date

Until further notice

Requirements

Bachelor's degree in Microbiology, Biology, Chemistry, or a related scientific field with 8+ years of experience in a regulated pharmaceutical or medical device environment, OR Master's degree in a related field with 5+ years of relevant experience
Experience with microbiological testing and environmental monitoring, particularly in regulated settings
Familiarity with investigation processes (e.g., OOS, OOT, or atypical results) and structured problem-solving approaches
Ability to develop and maintain GMP-compliant documentation (e.g., SOPs, test methods, protocols)
Working knowledge of cGMP and regulatory expectations, including data integrity principles
Experience using laboratory systems (e.g., LIMS or similar tools)
Clear communication skills with the ability to present technical information in an understandable way
Strong organizational skills and the ability to manage multiple responsibilities effectively
Experience in sterile manufacturing or contamination control environments
Exposure to regulatory inspections or audits within a microbiology function

Job Responsibility

Support and guide QC Microbiology activities at RLDD, including environmental monitoring, contamination control, and laboratory operations
Contribute to validation and lifecycle activities for microbiological methods, instruments, and laboratory systems, including qualifications, method transfers, and change assessments
Partner with cross-functional teams to evaluate microbiological risks, support issue resolution, and inform product quality decisions
Lead and support investigations (e.g., deviations, atypical results, EM excursions) using structured, science-based approaches to determine root cause and implement effective corrective actions
Prepare and maintain microbiology documentation such as SOPs, test methods, protocols, and contamination control strategy content, ensuring clarity and compliance with regulatory expectations
Perform laboratory assessments and data reviews to identify improvement opportunities and sustain a state of inspection readiness
Support adoption and continuous improvement of laboratory tools and systems (e.g., LIMS, EM systems, data trending tools) to strengthen efficiency and data integrity
Share knowledge and provide guidance to colleagues
contribute to audits and inspections by preparing documentation and responding to microbiology-related inquiries

What we offer

Support for Parents
Continuing Education/ Professional Development
Employee Heath & Well-Being Benefits
Paid Time Off
2 Days a Year to Volunteer
medical and dental coverage that start on day one
insurance coverage for basic life, accident, short-term and long-term disability, and business travel accident insurance
Employee Stock Purchase Plan (ESPP), with the ability to purchase company stock at a discount
401(k) Retirement Savings Plan (RSP), with options for employee contributions and company matching
Flexible Spending Accounts

Fulltime

Cmm operator ii

The Quality Control Inspector II will be responsible for executing Quality Contr...

Location

United States , Austin

Salary:

Not provided

Diasorin

Expiration Date

Until further notice

Requirements

HS Diploma or equivalent required
Associate's degree in a technical field preferred
5 years relevant work experience or training OR 7 years related experience without Associate's degree
Proficient knowledge of secondary finishing processes (i.e., plating, powder coating, polishing etc..)

Job Responsibility

Performing incoming dimensional inspection of precision machined, molded and electromechanical parts using hand tools
Performing inspections with Optical Comparator, Digital Microscope, Profilometer experience needed
Programming and operating Zeiss CMM and vision system using Calypso software
Process purchased materials for release
Application of GD&T practices
Take ownership and assist in core QC functions and associated activities relating to Incoming Product Control
Fulfill individual and departmental CAPP objectives
Assist and document the investigation and resolution of problems initiated through non-conformances, corrective action, customer complaints, and/or audit findings
Coordinate and/or conduct departmental maintenance and calibration of local measuring and monitoring devices
Schedule outsourced testing and services

What we offer

competitive salary and benefits package

Fulltime

Specialist, QC Systems

As the Specialist, QC Systems, you will support the design, implementation, and ...

Location

Canada , Vancouver

Salary:

76000.00 - 95000.00 CAD / Year

AbCellera Biologics

Expiration Date

Until further notice

Requirements

3+ years of experience managing quality systems in a GxP-regulated environment, with demonstrated application of global CMC/GMP requirements and relevant regulations and guidance
Bachelor’s degree in a relevant scientific or engineering discipline with 5+ years of industry experience in biotechnology, pharmaceuticals, or life sciences
Strong understanding and hands-on experience with quality management systems and continuous improvement principles, including their application to QC laboratory operations and regulated environments
Solid understanding of drug development processes from discovery through CMC development, with the ability to translate business and regulatory requirements into practical, compliant solutions
Experience supporting, configuring, or owning QC laboratory electronic systems (e.g., LIMS, LES, CDS) in a GMP-regulated environment, including system lifecycle management and change control
Proactive in identifying opportunities for improvement, with strong critical thinking and problem-solving skills

Job Responsibility

Supporting, maintaining, monitoring, and continuously improving the QC Quality Management System (QMS) framework and associated quality system processes in compliance with applicable global CMC/GMP requirements
Supporting the operation, administration, and lifecycle management of QC laboratory electronic systems (eSystems), ensuring they effectively support sample management, analysis, data acquisition, data review, and result reporting in compliance with global GMP, data integrity, and regulatory requirements
Contributing to the design, implementation, and evolution of the QC data architecture, identifying eSystem capabilities needed to support QC workflows, data integrity (ALCOA++), and phase-appropriate compliance
Supporting the Business Process Owner (BPO) for QC laboratory systems (e.g. LIMS, LES, CDS), overseeing system changes, enhancements, and upgrades throughout the system lifecycle
Overseeing and maintaining QC eSystems master data, including user roles, permissions, system configurations, and controlled data objects
Developing, reviewing, and maintaining GMP procedures, work instructions, controlled documentation, and training materials governing the compliant and effective use, administration, and data management of QC eSystems, including delivery of end-user training sessions
Providing QC eSystem support for investigations, deviations, and CAPAs, including data retrieval, audit trail review, and system impact assessments
Supporting qualification and computer system validation activities for QC systems (e.g., protocol and risk assessment review, validation deviations/exceptions, and lifecycle documentation)
Supporting QC eSystem licensing, user access, vendor relationships, and budgeting/forecasting for QC digital infrastructure
Collaborating cross-functionally with QC, Quality Systems, IT, Engineering, Validation, and external vendors to ensure QC eSystems are fit-for-purpose, compliant, and aligned with laboratory and business processes

What we offer

Equity
Annual bonus dependent on team and company performance
6% (non-match) RRSP contribution
CAD $1,500 annual Active Lifestyle Allowance
Annual vacation
Professional development opportunities
Comprehensive health benefits
Scientific and technical mentorship
Strong sense of community and connections through work, clubs, and socials

Fulltime

Manager, QC Systems

As the Manager, QC Systems, you will support the design, implementation, and ong...

Location

Canada , Vancouver

Salary:

94880.00 - 118600.00 CAD / Year

AbCellera Biologics

Expiration Date

Until further notice

Requirements

5+ years of experience managing quality systems in a GxP-regulated environment, with demonstrated application of global CMC/GMP requirements and relevant regulations and guidance
Bachelor's degree in a relevant scientific or engineering discipline with 8+ years of industry experience in biotechnology, pharmaceuticals, or life sciences
Strong understanding and hands-on experience with quality management systems and continuous improvement principles, including their application to QC laboratory operations and regulated environments
Solid understanding of drug development processes from discovery through CMC development, with the ability to translate business and regulatory requirements into practical, compliant solutions
Experience supporting, configuring, or owning QC laboratory electronic systems (e.g., LIMS, LES, CDS) in a GMP-regulated environment, including system lifecycle management and change control
Proactive in identifying opportunities for improvement, with strong critical thinking and problem-solving skills

Job Responsibility

Establishing, supporting, maintaining, monitoring, and continuously improving the QC Quality Management System (QMS) framework and associated quality system processes in compliance with applicable global CMC/GMP requirements
Supporting the operation, administration, and lifecycle management of QC laboratory electronic systems (eSystems), ensuring they effectively support sample management, analysis, data acquisition, data review, and result reporting in compliance with global GMP, data integrity, and regulatory requirements
Contributing to the design, implementation, and evolution of the QC data architecture, identifying eSystem capabilities needed to support QC workflows, data integrity (ALCOA++), and phase-appropriate compliance
Serving as the Business Process Owner (BPO) for QC laboratory systems (e.g. LIMS, LES, CDS), overseeing system changes, enhancements, and upgrades throughout the system lifecycle
Overseeing and maintaining QC eSystems master data, including user roles, permissions, system configurations, and controlled data objects
Developing, reviewing, and maintaining GMP procedures, work instructions, controlled documentation, and training materials governing the compliant and effective use, administration, and data management of QC eSystems, including delivery of end-user training sessions
Providing QC eSystem support for investigations, deviations, and CAPAs, including data retrieval, audit trail review, and system impact assessments
Supporting qualification and computer system validation activities for QC systems (e.g., protocol and risk assessment review, validation deviations/exceptions, and lifecycle documentation)
Managing QC eSystem licensing, user access, vendor relationships, and budgeting/forecasting for QC digital infrastructure
Collaborating cross-functionally with QC, Quality Systems, IT, Engineering, Validation, and external vendors to ensure QC eSystems are fit-for-purpose, compliant, and aligned with laboratory and business processes

What we offer

Equity
Annual bonus dependent on team and company performance
6% (non-match) RRSP contribution
CAD $1,500 annual Active Lifestyle Allowance
Annual vacation
Professional development opportunities
Comprehensive health benefits
Scientific and technical mentorship

Fulltime

Senior Research Associate

Seeking a QC Senior Research Associate with broad knowledge and expertise in ana...

Location

United States , San Diego

Salary:

60.00 - 69.00 USD / Hour

Beacon Hill

Expiration Date

Until further notice

Requirements

BS or equivalent in relevant discipline with a minimum of 2-5 years of relevant industry experience or Master’s degree in relevant discipline with a minimum of 0-1 years of relevant industry experience
Experience in pharmaceutical industry with a GMP testing focus, ideally covering the analytical method and testing lifecycle from development through commercial drug product testing, with experience in a GMP QC release testing role
Experience in optimizing methods with particular emphasis on cell-based potency assay, molecular biology assay, and protein chemistry assays
Significant experience in an FDA-regulated environment
Entrepreneurial spirit, with strong willingness to take on new challenges required to bring novel medicines to the clinic
Excellent organizational and communication skills

Job Responsibility

Collaborate with research, analytical development and process development teams to develop, qualify/validate AAV gene therapy analytical/molecular biology assays, chemical/biochemical assays, and cell-based biological potency assays, for process monitoring and product release and stability, e.g., compendial methods, HPLC, DLS, droplet digital PCR or qPCR, ELISA, and cell‑based potency assays
Participate in developing timelines, protocols and reports for assay transfers, qualifications/validations Contribute to establishing material specifications for drug substance and drug products
Author and review QC analytical/equipment SOPs, protocols, and reports as needed
Ensure the timely execution of all routine QC testing, data review, and preparation of summary reports May act as an analytical lab representative on a CMC team
Perform quality management activities such as deviation, CAPA, change control, investigation of OOS, OOT and anomalous results within the company QMS according to established procedures.
Maintain QC laboratory, track critical reagents and equipment logbooks, and ensure all the equipment is calibrated
Utilize the LIMS system to submit samples, enter data, and track samples.
Utilize statistical analysis software to generate assay control charts and recommend assay acceptance criteria.
Learn and become proficient in all laboratory instrument software to conduct testing

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QC Associate, Data Digitalization

Job Description

Job Responsibility

Requirements

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