CrawlJobs Logo

Cell Processing Qc Specialist

United States, Boston Employment contract 64300.00 - 71100.00 USD / Year · Job Posted May 27, 2026
Apply Position
Job Link Share

Job Description

The Cell Processing Quality Control Specialist I trains and becomes competent at performing, interpreting and reporting for quality control assays required for cellular product evaluation. Responsible for the quality control (QC) of reagents, supplies, facility environmental testing, laboratory equipment maintenance and QC performed in the Cell Manipulation Core Facility. The Cell Processing Quality Control Specialist I is responsible for QC procedures that are performed under the highest standards of quality in a timely manner while minimizing costs.

Job Responsibility

  • Follow the laboratory’s procedures for specimen handling and processing, test analyses, reporting and maintaining records
  • Accurately perform, analyze and demonstrate proficiency of the following tests at a minimum: automated and manual cell counts, including trypan blue viability testing, basic flow cytometry analysis (CD34, T subsets, 7AAD viability, etc.), potency assays such as CFUs, etc., basic microbiology cultures and gram stains (clinical and environmental)
  • Must interpret QC and test results, trends and respond/report according to procedure and policy
  • Adhere to the laboratory’s quality control policies, document all quality control activities, instrument and procedural calibrations and all maintenance performed
  • Follow the laboratory’s established policies and procedures whenever test systems are not within the laboratory’s established acceptable levels of performance
  • Document all corrective actions taken when test systems deviate from the laboratory’s established performance specifications
  • Identify problems that may adversely affect test performance or reporting of test results, correct the problems encountered or immediately notify the senior specialist or supervisor
  • Maintain records that demonstrate that proficiency testing samples are tested in the same manner as patient specimens
  • Follow regulations (FDA, CLIA, HIPAA, OSHA, state), standards (FACT, JC) and safety guidelines
  • If applicable, answer questions from clinicians or other lab personnel
  • Maintain complete records of all testing performed
  • Maintain general clean and organized appearance of the department
  • Ensure reagents/test kits have received dates, expiration dates, and if applicable, opened dates
  • Attend monthly department and any additional training/educational meetings
  • Participate in all applicable safety training sessions
  • Know the location and contents of the safety manual
  • Know the location/use of all applicable safety equipment
  • If needed, participate in government or regulatory agency inspections

Requirements

  • Associate degree in chemical, physical or biological science or medical laboratory required
  • Basic knowledge of general clinical laboratory practices, hematology and microbiology
  • Able to perform aseptic processing of samples for relevant tests
  • Ability to accurately perform simple laboratory math calculations
  • Ability to work closely with others, possess solid interpersonal and communication skills
  • Capable of working in a fast-paced environment
  • Capable of handling stress of producing accurate results under time constraints
  • Good judgment, problem solving and analytical skills
  • Requires attention to detail and interpersonal skills to effectively communicate with both laboratory and clinical staff within a complex, multi-organization environment
  • Entry level in for cellular product high complexity testing lab
  • Must qualify as Testing Personnel under CLIA as independent judgment is required for the high complexity work performed in the following areas: hematology, immunology, microbiology, and molecular biology
  • Experience in a clinical laboratory performing high complexity testing (may have been a part of an internship program)

Nice to have

  • Bachelor's degree in medical technology, clinical laboratory, chemical, physical or biological preferred
  • MT (ASCP) certification or International Cytometry Certification Exam (ICCE) or other laboratory certification preferred

Looking for more opportunities?

Search for other job offers that match your skills and interests.

Similar Jobs for

Cell Processing Qc Specialist

8 matching positions

GMP QC Specialist, CMC

Reporting to the Director, QA Operations, the GMP QC Specialist, CMC, will be re...
Location
Location
United States , Philadelphia
Salary
Salary:
Not provided
cabalettabio.com Logo
Cabaletta Bio Inc
Expiration Date
Until further notice
Flip Icon
Requirements
Requirements
  • Bachelor’s degree in scientific discipline
  • Advanced degree preferred
  • Minimum of 5 years’ hands-on experience in biopharmaceutical technical operations, QC operations and/or quality operations
  • Minimum of 2 years’ hands-on experience in GMP laboratory environment, with specific familiarity with cell and gene therapy release assay development, performance, and qualification
  • Specific experience performing or reviewing microbiological assays, including compendial methods (sterility, endotoxin, mycoplasma assays, APS, APV and Environmental Monitoring)
  • Experience interacting with external testing laboratories preferred
  • Working knowledge of GMP and ICH guidance and both US and international regulatory requirements
  • Highly organized, effective, and proactive communicator verbally and in writing. Able to work independently to appropriately prioritize work
  • Strong team orientation and passion for continuous self-development
  • Experience in industry or in a startup industrial setting is preferred
Job Responsibility
Job Responsibility
  • GMP Compliance: Ensure that all internal laboratory activities are maintained in accordance with internal data integrity practices and standards. Ensure that external laboratory activities comply with GMP regulations and guidelines. Stay current with regulatory requirements and industry standards related to GMP
  • Batch Review / Release: Perform full batch record review of all types of investigations
  • perform appropriate quality control review of all QC data generated by third parties
  • draft, review, and approve CoA (internal/external)
  • Investigations: Identify issues of non-compliance and work directly with the third party to resolve prior to batch release. Review and approve any out-of-specification investigations in a timely manner
  • Quality Control Procedures: Develop, implement, and maintain quality control procedures to monitor and assess internal laboratory processes, as well as the processes employed by external laboratories used to generate QC data. Conduct regular reviews to identify areas for improvement and initiate corrective action(s) as needed
  • Audits and Inspections: Assist in the planning and conducting of internal audits to assess compliance with data integrity standards and approved procedures (e.g. SOPs, test methods). Support audits of external laboratories as needed
  • Assay Qualification / Validation: Review and approve assay development, qualification and validation plans, data generated and reports. Provide primary QC support for all activities
  • Documentation Management: Oversee the creation, review, and approval of laboratory documentation, including SOPs, test methods, protocols, and reports. Ensure that the documentation is accurate, complete, and in compliance with GMP requirements. Ensure all Process Development (Analytical Development and Manufacturing Sciences & Technology) related documentation and data are reviewed and archived in a timely and accurate manner
  • Training and Education: Assist in providing training and guidance to Process Development personnel on GMP principles, procedures, and compliance requirements. Ensure that all team members are informed and adhere to quality control measures
What we offer
What we offer
  • health and retirement
  • PTO
  • stock option plans
Read More
Arrow Right

Specialist II, Product Quality Assurance

The Specialist, NC Product Quality Assurance (PQA) will be responsible for suppo...
Location
Location
United States , Durham, NC
Salary
Salary:
105000.00 - 145000.00 USD / Year
beamtx.com Logo
Beam Therapeutics
Expiration Date
Until further notice
Flip Icon
Requirements
Requirements
  • Bachelors or Advanced degree in a scientific discipline
  • 10+ years’ experience in the pharmaceutical/biotech industry in combination with drug substance/drug product manufacture, development and/or quality
  • Knowledge of aseptic processing, and/or cell and gene therapy is preferred
  • Apply Quality concepts and company policies to resolve issues of moderate complexity in an effective manner
  • Excellent verbal and written communication skills, detail-oriented personality, and ability to work collaboratively across functions
  • Knowledge of global regulations and standards
  • Strong team player that has a customer service approach and is solution oriented
  • Attention to detail and the ability to work individually as well as within a multi-disciplinary team
  • Excellent listening, communication and interpersonal skills with a team focus
  • Consistent delivery of high-quality work
Job Responsibility
Job Responsibility
  • Provide Quality oversight of on-the-floor activities including manufacturing shop floor presence during operations
  • Provide Quality oversight of QC testing
  • Responsible for ensuring GMP compliance with applicable procedures and production requirements in QC, manufacturing, and facilities operations
  • Responsible for assisting with product disposition activities of supply produced at the manufacturing facility
  • Real time review of batch records and labels
  • Review and approval of manufacturing discrepancies and associated CAPA’s
  • Communicating lot disposition pending issues to management
  • Aid in the development and ongoing improvement of applicable quality systems for the site
  • identifying gaps or improvements, authoring and approval of procedures, and providing training, as needed
  • Review and approve calibration and maintenance work orders and asset inductions
  • Fulltime
Read More
Arrow Right

Sr. Specialist I, Product Quality Assurance

The Sr. Specialist I, NC Product Quality Assurance (PQA) will be responsible for...
Location
Location
United States , Durham
Salary
Salary:
140000.00 - 185000.00 USD / Year
beamtx.com Logo
Beam Therapeutics
Expiration Date
Until further notice
Flip Icon
Requirements
Requirements
  • Bachelors or Advanced degree in a scientific discipline with 10+ years' experience in the pharmaceutical/biotech industry in combination with drug substance/drug product manufacture, development and/or quality
  • Knowledge of aseptic processing, and/or cell and gene therapy is preferred
  • Apply Quality concepts and company policies to resolve issues of moderate complexity in an effective manner
  • Excellent verbal and written communication skills, detail-oriented personality, and ability to work collaboratively across functions
  • Knowledge of global regulations and standards
  • Strong team player that has a customer service approach and is solution oriented
  • Attention to detail and the ability to work individually as well as within a multi-disciplinary team
  • Excellent listening, communication and interpersonal skills with a team focus
  • Consistent delivery of high-quality work
  • Ability to gown and work in a cleanroom environment
Job Responsibility
Job Responsibility
  • Provide Quality oversight of on-the-floor activities including manufacturing shop floor presence during operations
  • Provide Quality oversight of QC testing
  • Responsible for ensuring GMP compliance with applicable procedures and production requirements in QC, manufacturing, and facilities operations
  • Responsible for assisting with product disposition activities of supply produced at the manufacturing facility
  • Real time review of batch records and labels
  • Review and approval of manufacturing discrepancies and associated CAPA's
  • Communicating lot disposition pending issues to management
  • Aid in the development and ongoing improvement of applicable quality systems for the site
  • identifying gaps or improvements, authoring and approval of procedures, and providing training, as needed
  • Review and approve calibration and maintenance work orders and asset inductions
  • Fulltime
Read More
Arrow Right

Fulfillment Supervisor

The Fulfillment Supervisor is a key role responsible for ensuring the fulfillmen...
Location
Location
United States , Millbury
Salary
Salary:
Not provided
formlabs.com Logo
Formlabs GmbH
Expiration Date
Until further notice
Flip Icon
Requirements
Requirements
  • High school diploma or equivalent required
  • Minimum 1 year of supervisor experience required
  • Bachelor's degree preferred
  • Strong attendance and reliability
  • Excellent communication skills, both verbal and written
  • Fast, practical problem-solving mindset under pressure
  • Self-motivated and able to work independently
  • Confident leadership with a hands-on approach
  • Highly organized, with strong time and task management
Job Responsibility
Job Responsibility
  • Oversee all aspects of fulfillment processes, ensuring efficient workflow, adherence to schedules, and high-quality output
  • Actively support the Quality Control (QC) when needed
  • Ensure a safe, clean, and organized work environment at all times
  • Keep the fulfillment line running with zero downtime and no workflow interruptions
  • Learn and apply proper labeling practices and accuracy standards
  • Proactively shift team members as needed to eliminate bottlenecks or slowdowns
  • Monitor and address excessive cell phone usage, idle time, or distractions
  • Support inventory control processes and accuracy
  • Manage a small team of fulfillment specialists and work along with them
What we offer
What we offer
  • Medical, Dental, Vision
  • 3% match of yearly salary for 401(k)
  • EAP Program
  • In-office catering 3x per week
  • 120 hours of PTO per year
  • Fulltime
Read More
Arrow Right

Specialist Quality Control (Technical Resources)

In this vital role, you will be part of Amgen India’s (AIN) Quality Control (QC)...
Location
Location
India , Hyderabad
Salary
Salary:
Not provided
amgen.com Logo
Amgen
Expiration Date
Until further notice
Flip Icon
Requirements
Requirements
  • Industry related experience related to one or more of the following: Chemistry, Biochemistry, Cell Biology, Immunology, Microbiology
  • Quality Control laboratory experience
  • High school diploma / GED and 12 years of related experience OR Associate’s degree and 10 years of related experience OR Bachelor’s degree and 8 years of related experience OR Master’s degree and 6 years of related experience OR Doctorate degree and 2 years of related experience
  • Strong technical writing skills within a highly regulated environment
  • Working knowledge of cGMP regulations, practices, and trends pertaining to Quality Control
  • Excellent written and verbal communication skills, ability to work in a team matrix environment and build relationships with partners
  • Experience with various laboratory computer systems and applications
Job Responsibility
Job Responsibility
  • Managing document requests from the global QC Network, including intake, prioritization, and tracking to completion
  • Creating, authoring, revising, and coordinating workflows for a variety of controlled document types, ensuring completion within agreed timelines and in compliance with procedural requirements
  • Collecting, organizing, and analyzing data from multiple repositories (e.g., LIMS, electronic laboratory notebooks) to support document management activities
  • Facilitating information gathering and alignment across the QC Network and cross-functional partners to support document updates and process harmonization
  • Driving project deliverables to ensure timely and high-quality completion of assigned tasks and initiatives
  • Supporting issue identification and resolution, collaborating effectively across sites and functions to maintain operational continuity
  • Ensuring all controlled documents meet Amgen’s quality standards and comply with cGMP, safety, and other applicable regulatory requirements
  • Ensuring all assigned training requirements are completed, current, and compliant with cGMP standards
  • Identifying opportunities for continuous improvement to ensure alignment in document structure, formatting standards, and data retrieval/compilation practices across the network
Read More
Arrow Right
New

Housekeeping Supervisor

The Housekeeping Supervisor oversees the cleanliness and maintenance of all publ...
Location
Location
United States of America , Naples
Salary
Salary:
Not provided
fourseasons.com Logo
Four Seasons
Expiration Date
Until further notice
Flip Icon
Requirements
Requirements
  • High school diploma or equivalent experience required
  • Prior experience in a similar role preferred but not required
  • Strong leadership and organizational skills with the ability to effectively manage a team
  • Ability to read, write, and speak English
  • Excellent communication skills and the ability to interact with guests and team members professionally
Job Responsibility
Job Responsibility
  • Supervises and ensures that all public areas including food and beverage outlets banquet spaces restrooms lobbies and hallways are kept clean neat and presentable including overseeing vacuuming mopping dusting and other necessary cleaning tasks
  • Ensures mirrors furniture floors elevators and doors are spotless and free from marks
  • Monitors and inspects the cleanliness and maintenance of all public areas regularly addressing any issues promptly
  • Coordinates with the Engineering department for maintenance needs and communicates any concerns to Housekeeping management
  • Periodically inspects and oversees the cleaning of lobby restrooms employee locker rooms and other public spaces
  • Ensures all surfaces are cleaned stocked with necessary supplies and trash is removed
  • Responds to guest requests and inquiries while in the public areas providing assistance and direction when needed
  • Ensures all guest areas are safe accessible and inviting
  • Leads and motivates the team working harmoniously and professionally with co-workers and supervisors fostering a collaborative and supportive work environment
  • Assists in the supervision of the housekeeping team in the absence or during high-volume periods stepping in to support Guestroom Attendant and House Attendant duties when needed
What we offer
What we offer
  • Lucrative salary
  • Market-leading benefits package that includes Medical Dental Vision and 401K with employer matching all starting at 30 days
  • Time off plans starting on the day of hire
  • An opportunity to be a part of a cohesive team in an inclusive work environment
  • Complimentary and discounted hotel stays around the world
  • Wellbeing and mental health initiatives and focused company
  • Embracement and promotion of diversity in our workplace
  • Complimentary employee meals and beverages
  • Tuition reimbursement
  • Fulltime
Read More
Arrow Right
New

Housekeeping Supervisor

The Housekeeping Supervisor oversees the cleanliness and maintenance of all publ...
Location
Location
United States of America , Naples
Salary
Salary:
Not provided
fourseasons.com Logo
Four Seasons
Expiration Date
Until further notice
Flip Icon
Requirements
Requirements
  • High school diploma or equivalent experience required
  • Prior experience in a similar role preferred but not required
  • Strong leadership and organizational skills with the ability to effectively manage a team
  • Ability to read, write, and speak English
  • Excellent communication skills and the ability to interact with guests and team members professionally
Job Responsibility
Job Responsibility
  • Supervises and ensures that all public areas, including food and beverage outlets, banquet spaces, restrooms, lobbies, and hallways, are kept clean, neat, and presentable
  • Ensures mirrors, furniture, floors, elevators, and doors are spotless and free from marks
  • Monitors and inspects the cleanliness and maintenance of all public areas regularly, addressing any issues promptly
  • Coordinates with the Engineering department for maintenance needs and communicates any concerns to Housekeeping management
  • Periodically inspects and oversees the cleaning of lobby restrooms, employee locker rooms, and other public spaces
  • Responds to guest requests and inquiries while in the public areas, providing assistance and direction when needed
  • Leads and motivates the team, working harmoniously and professionally with co-workers and supervisors
  • Assists in the supervision of the housekeeping team in the absence or during high-volume periods
  • Works with Housekeeping management on inventory and stock takes of guest supplies, cleaning supplies, and chemicals required for public area and back-of-house cleaning
What we offer
What we offer
  • Lucrative salary
  • Medical, Dental, Vision, and 401K with employer matching all starting at 30 days
  • Time off plans starting on the day of hire
  • An opportunity to be a part of a cohesive team in an inclusive work environment
  • Complimentary and discounted hotel stays around the world
  • Wellbeing and mental health initiatives and focused company
  • Embracement and promotion of diversity in our workplace
  • Complimentary employee meals and beverages
  • Tuition reimbursement
  • Fulltime
Read More
Arrow Right
New

Product Manager

A mission-driven healthcare technology organization focused on improving health ...
Location
Location
United States , New York City; California
Salary
Salary:
Not provided
signifytechnology.com Logo
Signify Technology
Expiration Date
Until further notice
Flip Icon
Requirements
Requirements
  • Explicit and direct experience with Clinical Data and Healthcare Interoperability
  • Proven track record of owning product verticals within B2B SaaS Health Technology organizations, specifically in Data and Interoperability
  • Demonstrated progression across two or more Product Management roles
  • Extensive experience with healthcare data standards and interoperability protocols (FHIR, HL7, etc.)
  • Strong familiarity with Electronic Health Records (EHR) systems and integration ecosystems
  • Demonstrated ability to independently identify and solve problems within cross-functional product teams (Product, Design, Engineering)
  • Strong customer-facing experience, including leading discovery with both technical and non-technical stakeholders
  • Exceptional written and verbal communication skills in a fully remote environment
  • Experience working in distributed teams
  • Commitment to fostering diversity and inclusion across teams
Job Responsibility
Job Responsibility
  • Own the vision, strategy, and objectives for the Clinical Data vertical, building and evolving scalable data infrastructure that enables accurate measurement of product impact
  • Define and lead the interoperability product strategy, deepening integrations across major EHR platforms and expanding standards-based data exchange capabilities (FHIR, HL7)
  • Lead initiatives from discovery through development and release, ensuring alignment between product vision, technical execution, and business objectives
  • Conduct regular discovery conversations with customers and technical stakeholders to understand emergent needs, validate assumptions, and evolve product strategy accordingly
  • Draft clear, comprehensive Product Requirements Documents (PRDs) that articulate user problems, success metrics, and proposed solutions
  • Partner closely with Engineering, Design, and Customer Success teams to prioritize work, allocate resources, and ensure successful delivery of roadmap initiatives
  • Collaborate with Product and Engineering leadership to shape annual product roadmaps aligned to broader strategic objectives
  • Continuously iterate on the data strategy based on user behavior, integration performance, healthcare standards evolution, and measurable impact metrics
  • Serve as the internal point of contact for Clinical Data and Interoperability-related product questions, triaging feedback and resolving user issues
  • Proactively identify opportunities to improve product development processes, collaboration models, and delivery efficiency
  • Fulltime
Read More
Arrow Right