QC Manager Job at CESO, INC. (Akron)

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

Qc microbiology manager

We are a clinical-stage biotechnology company focused on discovering and develop...

Location

Canada , Vancouver

Salary:

105600.00 - 132000.00 CAD / Year

AbCellera Biologics

Expiration Date

Until further notice

Requirements

Deep, hands-on Microbiology experience in a regulated (GMP) QC environment
experience mentoring or leading team members working within microbiology labs or cleanroom/controlled environments
10+ years of hands-on QC microbiology experience in a GMP setting
Bachelor’s degree in Microbiology or a related life sciences field
clear communication and collaboration
calm, structured decision-making under pressure
strong ownership, accountability, and solutions-focused mindset
organized, detail-oriented, committed to inspection readiness and data integrity
ability to thrive in an environment requiring in-lab leadership, cross-functional coordination, and prioritization of operational needs

Job Responsibility

Serving as the QC Microbiology SME for key strategic decisions related to microbiology, including contamination control, microbiological method strategy, environmental monitoring, utilities monitoring, facility readiness, and risk-based testing approaches
Leading all Microbiology operations, including bioburden, endotoxin, microbial ID, growth promotion, EM sampling, water testing, and trending
Troubleshooting microbiological assays, contamination events, and EM deviations, ensuring timely and compliant resolution
Providing daily in-lab mentorship to the QC team, fostering strong technique, aseptic practices, and microbiological best practices
Ensuring microbiology labs and adjacent QC spaces remain inspection-ready, including GMP housekeeping and equipment readiness
Reviewing micro data packages, protocols, reports, and testing documentation for accuracy and adherence to ALCOA++ principles
Collaborating with Analytical Development, Quality Assurance, Materials, and Manufacturing teammates to ensure smooth operational flow and timely release/testing

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

Fulltime

QC Project Manager

We are seeking a Quality Control (QC) Project Manager to support medical facilit...

Location

United States , Grand Forks Air Force Base

Salary:

Not provided

Bodwé Professional Services

Expiration Date

Until further notice

Requirements

Minimum 4 years of project management experience OR 2 years of medical project management experience
Strong working knowledge of the Military Health System and Defense Health Agency
Familiarity with DHA Facilities Enterprise, Defense Health Networks (DHNs), and service-level facility planning organizations
Working knowledge of DoD medical space planning and design criteria, including SEPS
Proficiency in Microsoft Office Suite: Word, Excel, PowerPoint, Access, SharePoint, and Outlook
Experience with construction administration, documentation, and QA/QC processes
Strong understanding of industry standards for medical facility planning and design
Excellent written and verbal communication skills, with the ability to interact at a senior/executive level
Must have or be able to obtain and maintain a Real ID or Passport in order to undergo commercial airfare travel
Must have or be able to obtain and maintain a valid driver's license

Job Responsibility

Provide on-site project management support for SRM/O&M projects within MTFs
Conduct field surveys, requirements analysis, and stakeholder coordination
Prepare and deliver weekly status reports and project updates
Facilitate design reviews, prioritize work, and support relocation efforts
Coordinate outages and participate in project meetings with stakeholders
Perform continuous on-site surveillance of construction activities
Inspect contractor quality control processes and ensure compliance with contract requirements
Monitor testing requirements and maintain detailed project documentation
Maintain weekly progress photos and construction records
Review contractor submittals, shop drawings, and samples

Fulltime

Service Coordinator

We’re seeking driven, curious people who bring energy to what they do and see ch...

Location

United States , Deer Park

Salary:

Not provided

AWC

Expiration Date

Until further notice

Requirements

High School Diploma required
Bachelor's degree or equivalent preferred
Collaborative team player with strong verbal and written communication skills
Demonstrated leadership abilities with a proactive approach to problem-solving
Proficiency in Microsoft Office applications
Exceptional organizational skills with keen attention to detail
Effective time-management skills to handle multiple tasks simultaneously
Knowledge of material flow within shop operations preferred
Ability to work independently and collaboratively, taking direction when needed

Job Responsibility

Assists Inside Sales and Shop with Order Coordination
Sending material and equipment rental order to vendors and updating material costs
Code Material orders as need for both in-progress orders and shop consumables
Send Packing Slips to Shipping and Receiving
Follow up on past due to vendor orders
Notify Inside Sales of potential production issues due to material delays
Change and Update Service Orders
Authorize Technicians for Expenses
Change Tag Data Statuses
Process BOM Changes for orders in production, and review labor allocation

What we offer

Employee Stock Ownership Plan (ESOP)
401(K) Match
Competitive Pay
Medical, Dental and Vision Insurance Package
Employer Paid Life Insurance
Paid Time Off and Holiday Pay
Career Development Opportunities

Fulltime

Quality Control Manager

Location

United States , Various domestic locations

Salary:

Not provided

Caddell Construction

Expiration Date

Until further notice

Requirements

Engineer, Architect, or Construction Management Degree
Current professional engineer registration or current licensed architect
10 years construction experience and at least 4 years of experience as a QC Manager
Familiarity with EM 385-1-1 requirements
Experience with hazard identification, safety compliance, & sustainability
Obtain a Construction Quality Management Training Certification
Good written and verbal communication skills
Strong computer skills, especially Microsoft Office suite and web-based tools
Must have the ability to crawl, climb, walk, reach with hands and arms, bend, kneel, crouch, stand for longs periods of time, lift and hold in excess of 50lbs, talk, hear and occasionally sit
Must have the ability to withstand confined spaces and or/extreme heights while negotiating tasks at hand in a safe manner to themselves and/or others

Job Responsibility

Responsible for contract compliance and the administration and implementation of the quality control system as described in the Caddell Quality Control Manual for the assigned project
Identifies quality control problems and recommends, initiates and provides solutions to the problems and ensures no concealment of deficiencies
Ensures that company standards, as outlined in the Caddell Quality Control Manual, are effectively implemented and provides notification to corporate management of quality problems
Acts as liaison with owner, regulatory agencies, subcontractors and/or internal departments on quality related matters as required
Performs, schedules, and witnesses inspections and testing
Monitors construction activities and documents results
Issues reports to subcontractors regarding their quality deficiencies and remediation requirements
Ensures adequate corrective measures are implemented in cases of noncompliance
Reviews work for compliance
Maintains updated contract documents, drawings, specifications, as-builts, request for information and approved submittals

What we offer

Paid vacations
company-paid holidays
company-funded medical insurance
Company joint funding of dental and vision insurance
life and disability plans to full-time employees
401k match
gym membership reimbursement
use of company condominiums

Fulltime

Senior Director, Quality Assurance

Theradaptive is revolutionizing the field of therapeutic delivery with a pipelin...

Location

United States , Frederick

Salary:

Not provided

Theradaptive

Expiration Date

Until further notice

Requirements

Bachelor's degree (required) in Life Sciences, Biomedical Engineering, Chemistry, Biochemistry, or a related field
Advanced degree (M.S., Ph.D., or M.D.) strongly preferred
15+ years of progressive quality experience in the biopharmaceutical, biotech, or medtech industry, with at least 5 years in a senior leadership role (Director level or above)
Demonstrated experience with combination products, including working knowledge of both drug/biologic and device QMS frameworks
Direct experience managing FDA inspections (PAI, cGMP, QSR) and responding to 483 observations and Warning Letters
Hands-on experience with protein biologics or growth factors (e.g., rhPDGF, BMP, FGF, EGF, VEGF) in a GMP manufacturing or quality context
Experience with sterile or aseptic combination products is highly preferred
Expert-level knowledge of: 21 CFR Parts 210/211 (Drug cGMP), 21 CFR Part 820 / ISO 13485 (Device QMS), 21 CFR Part 4 (Combination Products)
Expert-level knowledge of: ICH Q7, Q8, Q9, Q10, Q11 guidelines
Expert-level knowledge of: ISO 14971 (Risk Management), ISO 10993 (Biocompatibility)

Job Responsibility

Design, implement, and own an integrated QMS that satisfies 21 CFR Parts 210/211 (drug/biologic GMP), 21 CFR Part 820 / ISO 13485:2016 (medical device QMS), and ICH guidelines (Q7, Q8, Q9, Q10)
Ensure the QMS addresses the regulatory designation of the combination product (PMOA-based lead center: CDRH or CDER) and the requirements of the non-lead center
Develop and maintain all quality policies, SOPs, work instructions, and quality plans across the product lifecycle
Drive QMS digital transformation initiatives, including electronic quality management platforms (e.g., Veeva Vault QMS, MasterControl, TrackWise)
Serve as the company's subject-matter expert on 21 CFR Part 3 (combination product designation), 21 CFR Part 4 (regulation of combination products), and applicable guidance documents
Lead cross-functional efforts to align quality requirements for both the protein growth factor drug/biologic constituent and the device constituent part throughout CMC development, scale-up, and commercialization
Oversee the integration of device design controls (21 CFR 820.30) with drug development quality requirements, ensuring alignment in risk management activities per ISO 14971
Collaborate closely with Regulatory Affairs on BLA, PMA, 510(k), or De Novo submission strategies — specifically quality module content (Module 3 / CTD, Design History File, Device Master Record)
Prepare and lead quality-related FDA interactions including pre-submission meetings, Agency responses, and inspection readiness activities
Support compliance with EU MDR 2017/745, IVDR, and country-specific registration requirements for international expansion

Application Support And Maintenance - Healthcare Provider

We are currently seeking a Application Support and Maintenance - Healthcare Prov...

Location

India , Noida

Salary:

Not provided

NTT DATA

Expiration Date

Until further notice

Requirements

Experience working within the Healthcare Provider domain, with a strong understanding of hospital workflows and operational support. Incident & Problem Management: Investigate, troubleshoot, and resolve L2/L3 incidents for COTS healthcare applications, ensuring timely restoration of services and adherence to SLAs
perform root cause analysis for recurring issues. Application Monitoring & Maintenance: Proactively monitor application health, interfaces, and batch jobs
perform regular maintenance, patch validation, and upgrades in coordination with vendors and internal teams. Change & Release Support: Assess, implement, and validate application changes (configurations, patches, upgrades) through controlled release processes, including impact analysis and rollback planning. Stakeholder & Vendor Coordination: Act as a liaison between business users, IT teams, and third-party vendors for issue resolution, enhancements, and escalations, particularly for regulated healthcare workflows. Compliance & Documentation: Maintain knowledge articles, runbooks, and audit documentation
ensure adherence to healthcare regulations (e.g., HIPAA), security standards, and data privacy requirements. Strong understanding of LIS workflows, QC, specimen processing, analyzer interfaces
Experience with middleware systems (ASTM/HL7), device interfaces, and autoverification
Skills supporting blood bank systems, barcode labeling (ISBT‑128), compliance (AABB, CAP)
Ability to troubleshoot orders/results loops, connectivity, validation
Knowledge of accreditation requirements, QC/QA reporting
Data extraction & reporting for lab leadership and operational metrics
Experience working with Laboratory systems like Merge LIS, Orchard Harvest, Softlab, Sunquest Lab and other similar applications

Job Responsibility

Investigate, troubleshoot, and resolve L2/L3 incidents for COTS healthcare applications, ensuring timely restoration of services and adherence to SLAs
perform root cause analysis for recurring issues. Proactively monitor application health, interfaces, and batch jobs
perform regular maintenance, patch validation, and upgrades in coordination with vendors and internal teams. Assess, implement, and validate application changes (configurations, patches, upgrades) through controlled release processes, including impact analysis and rollback planning. Act as a liaison between business users, IT teams, and third-party vendors for issue resolution, enhancements, and escalations, particularly for regulated healthcare workflows. Maintain knowledge articles, runbooks, and audit documentation
ensure adherence to healthcare regulations (e.g., HIPAA), security standards, and data privacy requirements

Fulltime

Qa Tech

We are looking for a dedicated Quality Control Technician to join our dynamic te...

Location

United States , Elizabethtown

Salary:

Not provided

GROWMARK FS, LLC

Expiration Date

Until further notice

Requirements

Normally requires a high school diploma, or the equivalent thereof, and 1 – 3 years or more of clerical related work experience to demonstrate knowledge of professional communication skills, typing proficiency and Microsoft Office programs
Strong organizational skills and attention to detail
Ability to multitask and manage time effectively in a fast-paced environment
Must have and maintain a valid driver's license and satisfactory driving record
Demonstrates essential abilities including business knowledge, collaboration, communication, customer focus, decision making and skill development

Job Responsibility

Pulls monthly germination reports and determines lots to be sampled using guidelines provided by management
Prepares sample envelopes and mark accordingly
Determines sample quantity and the appropriate lab for testing
Researches item history when discrepancies occur
Labels part containers and repackages if necessary
Compiles spreadsheets to send with seeds to the labs and to utilize for inventory markdowns in the system
Communicates via email/phone with suppliers and seed labs daily
Records lab results in computer system
Notes quality comments in system – restrictions, flags, off types, hybridity, etc
Advises appropriate people when results/quantities are in question

What we offer

401(k) & Employer Match
Medical, Dental, & Vision
HSA & Employer Contributions
Life Insurance
Disability
Identity Protection
Talent Community

Fulltime

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QC Manager

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