CrawlJobs Logo
Beam Therapeutics Logo Beam Therapeutics · Quality Control

Senior Specialist I/II, Analytical Instrument and Systems Qualification

United States, Durham, NC 140000.00 - 185000.00 USD / Year · Job Posted March 20, 2026
Apply Position
Job Link Share

Job Description

The Quality Control (QC) Specialist I/II—Analytical Instrument Qualification is responsible for the end‑to‑end onboarding, qualification, and lifecycle management of analytical instruments used in both Massachusetts and North Carolina GMP testing laboratories. The role authors and/or reviews core validation deliverables (URS, SIA, DIAS, CS, FDS), plans and executes risk‑based qualification (IQ/OQ/IOQ/PQ), maintains traceability, and ensures assets remain in a validated state through structured change control and periodic validation maintenance. Work is executed in accordance with internal procedures and associated work instructions/templates in Beam Quality Management System with specific attention to embedded software/data integrity expectations.

Job Responsibility

  • Lead or support onboarding of new analytical instruments, defining system boundaries, intended use, and qualification strategy in alignment with SIA and URS, including Draft, review, and secure approval of URS, SIA, DIAS, CS, and FDS deliverables
  • Author and execute IQ/OQ/IOQ/PQ protocols (as appropriate), ensuring test pre‑requisites, evidence, and deviations are documented and resolved prior to release for GMP use
  • Build and maintain the Requirements Traceability Matrix (RTM) to link requirements (URS/DIAS/CS/FDS) through protocol test cases and results
  • compile a Qualification Summary Report (QSR) to close projects
  • Define and verify data integrity and computerized system controls per DIAS (e.g., access management, audit trails, e‑records/e‑signatures, backup/recovery, calculations, data flows/interfaces) for instruments with embedded or attached control software
  • Initiate and/or execute change controls for instrument configuration changes, software upgrades, relocations, and method impacts
  • perform impact assessments and define re‑qualification needs
  • Perform/participate in periodic validation maintenance reviews to confirm lifecycle documents (SIA, URS, DIAS, CS, FDS, RTM, QSR) remain current and that assets stay in a validated state
  • Partner with QC SMEs, Digital Quality & Data Integrity, Validation, QA, IT, Facilities/Metrology, and vendors to plan and deliver qualification on schedule
  • coordinate service/vendor activities for installation, calibration, and PM in support of qualification and sustainment
  • Support internal/external audits and health authority inspections as the qualification/validation point of contact for assigned instruments, providing rationales, traceability, and documented evidence
  • Lead or support investigations and CAPAs related to instrument performance, data integrity, or qualification gaps, ensuring timely closure and documented effectiveness checks

Requirements

  • Bachelor’s or Master’s degree required, preferably in a life science discipline with 10-12 years’ experience
  • Working understanding of various analytical techniques primarily flow cytometry, plate based assays, automated liquid handling, liquid chromatography, capillary electrophoresis, and next generation sequencing
  • Experience qualifying and sustaining a range of QC instruments (e.g., HPLC/UPLC, GC, CE, UV‑Vis, FTIR, TOC, qPCR/plate readers, balances, pH meters, osmometers, NGS, Flow Cytometers), including networked data systems and interfaces
  • Working knowledge of applicable regulatory expectations for e‑records/e‑signatures and computer systems (e.g., Part 11/Annex 11), with successful inspection support
  • Experience collaborating across multi‑site QC organizations and with equipment vendors to deliver validation to plan
  • Technical writing skills
  • Ability to work independently in a high-paced team environment, meet deadlines, and prioritize work from multiple projects
  • Advanced ability to communicate effectively with peers, department management and cross-functional peers
  • Documentation Excellence: Clear, complete, and audit‑ready authorship of URS, SIA, DIAS, CS, FDS, protocols, RTM, and QSR
  • Systems Thinking: Ability to define system boundaries, dependencies, and data flows
  • translate requirements into testable specifications and traceability
  • Quality Mindset: Applies risk‑based, phase‑appropriate validation
  • maintains validated state through disciplined change control and periodic review
  • Collaboration & Influence: Works effectively with QA/Validation/IT/Digital Quality & Data Integrity, lab users, and vendors to resolve issues and meet milestones
Beam Therapeutics - All Job Offers

Looking for more opportunities?

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

Suggested Tags: Frontend Developer Secretary Talent Manager Salesforce Administrator Data Analyst
Similar Jobs for

Senior Specialist I/II, Analytical Instrument and Systems Qualification

8 matching positions

Cook

Do you love to cook? Are you passionate about food? As a Cook on our team, you’l...
Location
Location
United States , Crowell
Salary
Salary:
Not provided
aramark.com Logo
Aramark
Expiration Date
Until further notice
Flip Icon
Requirements
Requirements
  • Experience as a cook or in a related role required
  • Validated knowledge of the basic principles of food preparation, various cooking methods, and food safety regulations such as accurate food handling, sanitation, and storage
  • Must be able to acquire food safety certification
  • Demonstrate basic math and counting skills
  • Demonstrates interpersonal communication skills, both written and verbal
Job Responsibility
Job Responsibility
  • Cooks and prepare a variety of food according to production guidelines and standardized recipes
  • Sets up workstation with all needed ingredients and equipment
  • Prepares ingredients by measuring, weighing, mixing, chopping, trimming, and peeling food items
  • Safely uses a variety of utensils including knives
  • Operates equipment such as ovens, stoves, slicers, mixers, etc.
  • Bakes, roasts, broils, steams, and uses a variety of cooking methods on meat, vegetables, and other foods
  • Arranges, garnishes, and portions food according to established guidelines
  • Properly stores food by adhering to food safety policies and procedures
  • Cleans and sanitizes work areas, equipment, and utensils
  • Maintains excellent customer service and positive demeanor towards guests, customers, clients, co-workers, etc.
Read More
Arrow Right

Sr Manager, Engineering

The Experimentation team provides cutting edge tooling and methodologies for all...
Location
Location
United States , San Francisco
Salary
Salary:
267000.00 - 297000.00 USD / Year
uber.com Logo
Uber
Expiration Date
Until further notice
Flip Icon
Requirements
Requirements
  • Bachelor's or Master's degree in Computer Science or a related technical field, or equivalent experience in an engineering related bootcamp
  • 5+ years experience as an engineering manager
  • 5+ years of experience as a software engineer or equivalent
  • Experience going through the full software cycle of requirements, design, coding / testing, rollout / deployment, and best practices in delivering world-class software and services
  • Experience evolving and presenting a strong vision/roadmap for your team
  • Passion about your team's mission and the self-starting personality to make things happen
  • A track record of building teams with a culture of craftsmanship and engineering excellence
  • A track record of delivering results even when requirements are under-specified
  • Strong grasp of distributed-systems fundamentals: caching, sharding, consensus, fault tolerance, observability, and incident response
  • Excellent written and verbal communication skills, including the ability to document system architectures and algorithms
Job Responsibility
Job Responsibility
  • Grow, mentor, and develop teams of skilled software engineers and engineering managers within Measurement & Optimizations org
  • Recruit high quality engineering talent for the team as needed
  • Establish relationships and collaborate with key stakeholders across Uber to further the team goals
  • Own the definition, execution, and delivery of KPIs for your teams
  • Uphold a high bar for engineering excellence and platform reliability
  • Define the processes and systems within the team to positively shape engineering culture
  • Help define the roadmap and vision for Experimentation
What we offer
What we offer
  • Uber's bonus program
  • possible equity award
  • 401(k) plan
  • various benefits
  • Fulltime
Read More
Arrow Right

Engineering Manager II, Evaluation & Simulation - AV Labs

Uber is launching AV Labs to accelerate the autonomous technology ecosystem. We'...
Location
Location
United States , Sunnyvale
Salary
Salary:
232000.00 - 258000.00 USD / Year
uber.com Logo
Uber
Expiration Date
Until further notice
Flip Icon
Requirements
Requirements
  • 3 years of experience in software engineering management
  • 3 years of experience in the AV industry
  • 8 years of experience in the software engineering industry
  • Bachelor degree in computer science, computer engineering or related fields
  • Proficient in AV evaluation metrics and simulation technologies
Job Responsibility
Job Responsibility
  • Define the roadmap for AV evaluation and simulation
  • Define evaluation metrics for AV stack and drive technical architecture design
  • Communicate progress, opportunities and risks to leadership
  • Hire a high performing team. Raise the bar on engineering quality
What we offer
What we offer
  • participation in Uber's bonus program
  • equity award & other types of comp
  • 401(k) plan
  • various benefits (see link)
  • Fulltime
Read More
Arrow Right

Cook

Do you love to cook? Are you passionate about food? As a Cook on our team, you’l...
Location
Location
United States , Katy
Salary
Salary:
Not provided
aramark.com Logo
Aramark
Expiration Date
Until further notice
Flip Icon
Requirements
Requirements
  • Experience as a cook or in a related role required
  • Validated knowledge of the basic principles of food preparation, various cooking methods, and food safety regulations such as accurate food handling, sanitation, and storage
  • Must be able to acquire food safety certification
  • Demonstrate basic math and counting skills
  • Demonstrates interpersonal communication skills, both written and verbal
Job Responsibility
Job Responsibility
  • Cooks and prepare a variety of food according to production guidelines and standardized recipes
  • Sets up workstation with all needed ingredients and equipment
  • Prepares ingredients by measuring, weighing, mixing, chopping, trimming, and peeling food items
  • Safely uses a variety of utensils including knives
  • Operates equipment such as ovens, stoves, slicers, mixers, etc.
  • Bakes, roasts, broils, steams, and uses a variety of cooking methods on meat, vegetables, and other foods
  • Arranges, garnishes, and portions food according to established guidelines
  • Properly stores food by adhering to food safety policies and procedures
  • Cleans and sanitizes work areas, equipment, and utensils
  • Maintains excellent customer service and positive demeanor towards guests, customers, clients, co-workers, etc.
Read More
Arrow Right

Engineering Manager II - AI & Security

Location
Location
Netherlands , Amsterdam
Salary
Salary:
Not provided
uber.com Logo
Uber
Expiration Date
Until further notice
Flip Icon
Requirements
Requirements
  • Proven engineering leadership experience managing teams in platform, infrastructure, or related domains at scale
  • Strong ability to operate in ambiguous problem spaces and translate them into clear technical direction
  • Working knowledge of security fundamentals (e.g., access control, data protection, secure system design), with the ability to partner effectively with domain experts
  • Experience building or working with ML/AI-driven systems
  • Track record of shipping and scaling production systems
  • Strong collaboration and communication skills across engineering, product, and security stakeholders
Job Responsibility
Job Responsibility
  • Lead and grow a high-performing team of software engineers and applied scientists, setting a high bar for execution, technical rigor, and collaboration
  • Define and drive the roadmap for security and AI-driven systems, translating ambiguous problem spaces into clear priorities and deliverables
  • Build intelligent systems that automate detection, classification, and remediation of risks across code, data, and infrastructure
  • Secure AI-powered applications through continuous evaluation, monitoring, and defense against emerging threats (e.g., prompt injection, data leakage, model misuse)
  • Partner with infrastructure, data, and product teams to embed security controls and signals into the developer ecosystem
  • Scale systems and processes that improve security posture while maintaining developer velocity
  • Fulltime
Read More
Arrow Right

Chef de Cuisine

Aramark Sports & Entertainment is seeking a Chef de Cuisine for Fenway Park, hom...
Location
Location
United States , Boston
Salary
Salary:
70000.00 - 80000.00 USD / Year
aramark.com Logo
Aramark
Expiration Date
Until further notice
Flip Icon
Requirements
Requirements
  • Requires 2-3 years of experience in a related position
  • Requires 2-3 years of post-high school education or equivalent experience
  • Culinary degree preferred
  • Requires advanced knowledge of the principles and practices within the food profession
  • Requires experiential knowledge of management of people and/or problems
  • Requires oral, reading and written communication skills
Job Responsibility
Job Responsibility
  • Train and manage kitchen personnel and supervise/coordinate all related culinary activities
  • Estimate food consumption and requisition or purchase food
  • Select and develop recipes as well as standardize production recipes to ensure consistent quality
  • Establish presentation technique and quality standards, and plan and price menus
  • Ensure proper equipment operation/maintenance and ensure proper safety and sanitation in kitchen
  • Oversee special catering events and may also offer culinary instruction and/or demonstrates culinary techniques
What we offer
What we offer
  • medical
  • dental
  • vision
  • work/life resources
  • retirement savings plans like 401(k)
  • paid days off such as parental leave and disability coverage
  • Fulltime
Read More
Arrow Right

Campus Police Officer I and II

The Campus Police Officer serves as a vital member of the Department of Communit...
Location
Location
United States , Holyoke
Salary
Salary:
Not provided
hcc.edu Logo
Holyoke Community College
Expiration Date
Until further notice
Flip Icon
Requirements
Requirements
  • Possess or have the ability to obtain and maintain a Class A license to carry firearm (M.G.L. c.140, section 131)
  • Possess and maintain a valid Motor Vehicle Operator’s License
  • Knowledge of police procedures and practices, the law of arrest, and criminal procedures
  • Strong written and verbal communication skills, including the ability to prepare written reports
  • Reliable transportation in order to travel to and from meetings, trainings, or campus and community locations as required
  • Possess physical stamina and endurance
  • Must be able to meet the requirements of Chapter 253 of the Acts of 2020 (Police Reform Bill): Candidates must be 21 years of age at the time of hire
  • Applicants must have at least (A) two years of full-time, or equivalent part-time, experience in a governmental police force or in law enforcement work, or (B) any equivalent combination of the required experience
  • Successful completion of a Municipal Police Training Committee (MPTC)-approved basic training program
  • All candidates must complete Peace Officer Standards and Training Commission (POST) -approved physical and psychological fitness evaluation
Job Responsibility
Job Responsibility
  • Ensure and maintain a secure campus environment
  • investigate complaints and reports of suspicious activity
  • control crowds as necessary
  • Provide protection and security of persons, facilities and property
  • Patrol campus buildings and adjacent area(s) via foot, bike or Campus Police vehicle
  • Enforce college and department policies, rules and regulations, local laws, Massachusetts General Laws, and federal laws
  • Exercise police powers by making arrests, searching persons, and/or restraining and transporting violent persons
  • advise suspects of their constitutional rights to prosecute violators and to prevent further violations of law
  • Investigate all crimes, including theft, assault and battery, sexual assault, motor vehicle accidents, and other related incidents. Interview witnesses, victims and others
  • mediate disputes
  • Fulltime
Read More
Arrow Right

Land Development Manager

This position is primarily responsible for managing all off-site development act...
Location
Location
United States , Millville
Salary
Salary:
Not provided
beazer.com Logo
Beazer Homes
Expiration Date
Until further notice
Flip Icon
Requirements
Requirements
  • College graduate, with degree in engineering, architecture, construction or planning preferred
  • At least 2 years of experience in construction and/or development with knowledge of engineering drawings and setting schedules for development
  • PE/PMP preferred
Job Responsibility
Job Responsibility
  • Managing all off-site development activities
  • Performing all aspects of contract process
  • Reviewing and tracking all offsite plans
  • Initiating, tracking and maintaining all Development budgets
  • Maintaining all approvals and permissions to proceed in regards to permitting
  • Working closely with builders and Forward Planning Department
  • Managing bonds
  • Organizing Development Department by maintaining and directing personnel
What we offer
What we offer
  • Employee wellbeing and life-work balance
  • Development opportunities
  • Flexible time-off program
  • Industry leading parental leave policy
  • Fulltime
Read More
Arrow Right