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Job Opening for QC Specialist II

TalentBurst, Inc.

Portsmouth, NH

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JOB DETAILS
SKILLS
Analysis Skills, Assays, Biochemistry, Biotech and Pharmaceutical, Change Control, Communication Skills, Continuous Improvement, Corrective Action, Corrective and Preventative Action (CAPA) Systems, Cross-Functional, Data Analysis, Data Quality, Detail Oriented, Documentation, GMP (Good Manufacturing Practices), Identify Issues, Instrumentation, Investigative Reports, Laboratory Analysis, Laboratory Information Management System (LIMS), Laboratory Management, Laboratory Operations, Laboratory Systems, Maintain Compliance, Microbiology, Microsoft Excel, Microsoft Office, Microsoft PowerPoint, Microsoft Word, Multitasking, Operational Support, Presentation/Verbal Skills, Problem Solving Skills, Procedure Development, Production Support, Quality Assurance Methodology, Quality Control, Record Keeping, Regulations, Regulatory Compliance, Regulatory Requirements, Root Cause Analysis, Software Validation, Team Player, Technical Operations, Technical Support, Test Scripts, Testing, Training/Teaching, Validation Documentation, Writing Skills
LOCATION
Portsmouth, NH
POSTED
30+ days ago
Title: QC Specialist II
Location: Portsmouth NH
Duration: 12 Months
100% On site

Note - SAME JOB AS LZAJP00006337 - MANAGER WAS NOT INTERESTED IN CANDIDATES SUBMITTED TO THAT JOB, SO PLEASE DON'T RESUBMIT TO THIS ONE.

Position Overview
We are seeking a QC Specialist II to join the Quality Control team in Portsmouth, NH. This role supports production and laboratory operations through technical transfer activities, analytical testing, and quality system documentation within a GMP-regulated pharmaceutical environment.
The QC Specialist II will perform in-process, lot release, and stability testing, support method transfers and validations, and contribute to quality investigations and continuous improvement initiatives. The ideal candidate will have experience working with GMP quality systems, laboratory software, and analytical instrumentation while ensuring compliance with data integrity and regulatory requirements.

Key Responsibilities
Quality Control & Analytical Testing
  • Perform analytical testing for in-process samples, lot release, and stability studies.
  • Conduct testing to support investigations, method transfers, and validation activities.
  • Review analytical assays and laboratory results to ensure accuracy and compliance.
  • Support laboratory operations by troubleshooting testing issues and identifying deviations from standard procedures.
Technical Transfer & Laboratory Projects
  • Support technical transfer activities within the Quality Control laboratory.
  • Participate in method transfers, new instrument implementation, and method qualification projects.
  • Assist with the validation and qualification of laboratory software and analytical systems.
  • Serve as a Subject Matter Expert (SME) for at least one laboratory software system.
Quality Systems & Documentation
  • Author and review GMP documentation, including:
    • Deviations
    • CAPA records
    • Change controls
    • Investigation reports
    • Test methods and procedures
  • Participate in root cause investigations and support corrective and preventive actions.
  • Ensure compliance with data integrity (DI) policies, procedures, and regulatory requirements.
  • Maintain accurate laboratory records in accordance with GMP and regulatory guidelines.
Collaboration & Communication
  • Communicate with cross-functional teams to support project priorities and technical needs.
  • Provide training and guidance to other team members when needed.
  • Interpret analytical data and present findings to internal stakeholders.
  • Participate in team meetings and contribute to continuous improvement initiatives.

Required Qualifications
  • Associate's Degree in Microbiology, Biochemistry, or a related scientific field.
  • Experience working in a GMP-regulated pharmaceutical or biotechnology environment.
  • Experience with quality systems and documentation including deviations, CAPA, investigations, and change control.
  • Strong understanding of data integrity principles and regulatory compliance.
  • Ability to analyze data, troubleshoot issues, and support root-cause investigations.
  • Strong written and verbal communication skills
Technical Skills
Experience with the following systems and software is preferred:
  • SoftMax Pro
  • Empower
  • SoloVPE
  • LIMS
  • TrackWise
  • Microsoft Office Suite (Word, Excel, PowerPoint)
Additional experience with software validation activities, including writing GMP procedures, validation documents, and executing test scripts, is highly desirable.
Core Competencies
  • Strong analytical and problem-solving skills
  • Ability to manage multiple priorities and projects
  • Excellent communication and teamwork skills
  • High attention to detail and commitment to quality and compliance
  • Self-motivated with the ability to work independently and within a team environment
#TB_PH
#ZRPH

Why TalentBurst?
At TalentBurst, we deliver more than talent, we deliver outcomes. We partner with you to move quickly and connect you to opportunities aligned with your skills and long term growth.

Backed by precision, transparency, and results, we connect top talent with leading organizations through trusted partnerships.

We offer competitive compensation and comprehensive benefits, including medical, dental, vision, and retirement options.

TalentBurst is an equal opportunity employer committed to an inclusive and diverse workforce.

About the Company

T

TalentBurst, Inc.

For over 20 years, TalentBurst Inc. has been an award-winning provider of cutting-edge Workforce Management Solutions. With a strong commitment to staying ahead in the tech landscape, we pioneer innovative approaches to talent acquisition. Our expertise spans Life Sciences, and Healthcare Staffing, Banking, Financial, IT, and Engineering, as well as Global Employer of Record (EOR), Agent of Record (AOR), State, Local Government and Education (SLED), and IC validation/compliance services. Additionally, our division, TalentProcure, leads the industry with offerings such as High Hazard Payroll, Managed Services, and Vendor on Premise (VOP) solutions.

Due to our prioritization of excellent standards, we are Joint Commission Certified and are a certified Minority Business Enterprise (MBE) in the USA and Canada. Supporting over 130 Fortune 500 companies globally, we excel in navigating the landscape of talent acquisition. In a world of constant change, we embrace developing people-centric solutions that address the unique demands of our clients. Stay connected by visiting our website and following us on social media!

 

COMPANY SIZE
5,000 to 9,999 employees
INDUSTRY
Staffing/Employment Agencies
FOUNDED
2002
WEBSITE
http://www.talentburst.com/