Analyst 3 - Quality Assurance

Two to four (2-4) years of experience working within the biotherapeutic and/or pharmaceutical industry and knowledge in compliance of commissioning, qualification and validation of GMP processes and systems such as Utilities (water for injection, clean steam, process gases, HVAC, SIP/CIP), fridges, freezers, LAF, BSC units, autoclaves and isolators – as well as Process Equipment – Bioreactors, UF/DF, centrifuge, Chromatography systems. Essential Job Duties and Responsibilities This position is responsible for ensuring compliance with regulatory requirements and company policies following current Good Manufacturing Practices, client's Policies and internal procedures through the following duties and responsibilities: Ensure the site validation program has been developed and maintained in compliance with all regulatory and corporate requirements and Master Plans.

Join a Global Leader in Workforce Solutions – Net2Source Inc.

Who We Are
Net2Source Inc. isn't just another staffing company, we're a powerhouse of innovation, connecting top talent with the right opportunities. Recognized for 300% growth in the past three years, we operate in 34 countries with a global team of 5,500+. Our mission? To bridge the talent gap with precision—Right Talent. Right Time. Right Place. Right Price.

Join a Global Leader in Workforce Solutions – Net2Source Inc.
 
Who We Are:
Net2Source Inc. isn't just another staffing company, we're a powerhouse of innovation, connecting top talent with the right opportunities. Recognized for 300% growth in the past three years, we operate in 34 countries with a global team of 5,500+. Our mission? To bridge the talent gap with precision—Right Talent. Right Time. Right Place. Right Price.
 
Role: Analyst 3 - Quality Assurance
Duration of Contract: 5 months with possible extension
Location: Wilson, NC 27893
Pay Rate: $62.51/hr on W2, no benefits
 
Description:
 
Quality Specialist
 
Essential Job Duties and Responsibilities

• This position is responsible for ensuring compliance with regulatory requirements and company policies following current Good Manufacturing Practices, client's Policies and internal procedures through the following duties and responsibilities:
• Ensure the site validation program has been developed and maintained in compliance with all regulatory and corporate requirements and Master Plans.
• Works with the applicable qualification teams representing Quality Assurance in the requirement, design review, construction, qualification and leveraging documentation strategies, cleaning development/validation and implementation of project. 
• Review and approve commissioning and qualification documentation, including URS (User Requirements Specifications), IQ (Installation Qualification), OQ (Operational Qualification), and PQ (Performance Qualification) protocols and reports, SOP's, Work Instructions and any other technical document.
• Review and approves validation protocols and reports (analytical, cleaning, process, etc.)
• Provide quality oversight for C&Q/CSV and validation execution activities to ensure compliance with GMP, FDA, EMA, and other regulatory requirements.
• Support the development and implementation of C&Q and validation plans, ensuring alignment with project timelines and deliverables.
• Perform QA reviews of system impact assessments and categorization of equipment and utilities.
• Ensure compliance with company quality standards, including SOPs, work instructions, and quality policies.
• Act as the QA point of contact for deviations, CAPAs, and change controls related to C&Q and validation activities.
• Provide recommendations for process improvements to enhance compliance and efficiency in C&Q and validation activities.
• Reviews/approves Technology Transfer documents assuring they meet regulatory and J&J requirements.
• Collaborate with cross-functional teams, including engineering, validation, and manufacturing, to address quality issues.

 
Additional Job Duties and Responsibilities:

• Provides support and direction to all departments in respect of specific quality system elements to ensure business, quality and compliance goals are met following the J&J Standards. 
• Partners with other Departments to ensure that compliance systems are implemented in an efficient manner. 
• Develops and implements processes, procedures, forms, work instructions and tools related to the implementation of compliance systems at the site.
• Carries out tasks related to the administration of site nonconformance management, change control and training systems and its applicable Electronic Tracking System (ETS).  
• Develops and implements processes, procedures and tools related to the implementation of compliance systems at the site.
• Collaborate with cross-functional teams (Operations, Engineering & Maintenance, MSAT, QC, etc) to address quality issues.
• Provides support to documentation review through evaluation and approval of documentation related to regulatory submissions, standard operating procedures (SOPs), and quality management systems to ensure accuracy and compliance as required.

 
Minimum Qualification

• Bachelor's degree in a scientific or engineering discipline is required.
• Two to four (2-4) years of experience working within the biotherapeutic and/or pharmaceutical industry and knowledge in compliance of commissioning, qualification and validation of GMP processes and systems such as Utilities (water for injection, clean steam, process gases, HVAC, SIP/CIP), fridges, freezers, LAF, BSC units, autoclaves and isolators – as well as Process Equipment – Bioreactors, UF/DF, centrifuge, Chromatography systems. 
• Strong understanding of cGMP, FDA, EMA, ICH guidelines, and ISPE Baseline Guides. Hands-on experience with qualification/validation lifecycle (URS, FAT, SAT, IQ, OQ, PQ) and cleaning/process validation.
• Familiarity with ISPE guidelines, including GAMP 5, ASTM E2500, and validation lifecycle principles.
• Strong understanding of risk-based approaches to commissioning and qualification/validation.
• Proficiency in technical writing for validation and quality documents.
• Strong communication and interpersonal skills for cross-functional collaboration.

 
Other requirements

• An unquestionable level of integrity and commitment to operating ethically and within the boundaries of regulatory requirements.
• Excellent communication and interpersonal skills, with the ability to effectively collaborate with cross-functional teams.
• Proven ability to manage multiple priorities and work independently with minimal supervision.
• Detail-oriented mindset, with a keen eye for identifying opportunities for process improvements.
• Proven ability to prioritize tasks and meet deadlines in a dynamic manufacturing environment.
• Ability to build and nurture strong and positive relationships.

The ability to work in a team environment and interact with all levels of the organization.

Why Work with Us?
We believe in more than just jobs—we build careers. At Net2Source, we champion leadership at all levels, celebrate diverse perspectives, and empower you to make an impact. Think work-life balance, professional growth, and a collaborative culture where your ideas matter.

Our Commitment to Inclusion & Equity
Net2Source is an equal opportunity employer, dedicated to fostering a workplace where diverse talents and perspectives are valued. We make all employment decisions based on merit, ensuring a culture of respect, fairness, and opportunity for all, regardless of age, gender, ethnicity, disability, or other protected characteristics.

Awards & Recognition
• America's Most Honored Businesses (Top 10%)
• Fastest-Growing Staffing Firm by Staffing Industry Analysts
• INC 5000 List for Eight Consecutive Years
• Top 100 by Dallas Business Journal
• Spirit of Alliance Award by Agile1