Senior Specialist Quality Assurance - Level III (Senior)

Net2Source Inc. is an award-winning total workforce solutions company recognized by Staffing Industry Analysts for our accelerated growth of 300% in the last 3 years with over 5500 employees globally, with over 30 locations in the US and global operations in 32 countries. We believe in providing staffing solutions to address the current talent gap - Right Talent - Right Time - Right Place - Right Price and acting as a Career Coach to our consultants.

Job Title: Senior Specialist Quality Assurance - Level III (Senior)

Location: Durham, NC 27712

Duration: 12 Months

Pay Rate: $55.15/Hr on W2

Qualifications

Quality Assurance professional with at a minimum a BS Biology, Microbiology, Pharmacy, Chemistry, Chemical Engineering (or equivalent) and at least 5 years experience in the Pharmaceutical Industry.

Must have working knowledge of regulatory expectations for the manufacture and testing of sterile pharmaceutical products with experience in quality assurance oversight of sterile manufacturing, sterile process validation and/or sterile process technology transfer.

Must have 3 years of experience with development, review, and approval of User Requirement (URS), FAT, Installation Qualification (IQ), Operational Qualification (OQ), Performance Qualification (PQ) for pharmaceutical and biotechnology manufacturing equipment, facilities and utilities.

Responsibilities

Preferred experience in the assessment and preparation of manufacturing sites for Pre-Approval inspections by Regulatory agencies for new products.

• Reporting to the Quality Assurance Organization, will independently manage project assignments.
• Must have strong demonstrated interpersonal, communication, negotiation, and persuasion skills. Must have very strong relationship building skills.
• Immediate project support on review and approval of commissioning and qualification (C&Q) documents to support project delivery.
• Provide QA support including critical / constructive review and approval of GMP documentation such as Quality Agreements, Quality Risk Assessments, URS, FAT, IQ, OQ, PQ, other technical documents, change management, and manufacturing/batch documents to meet schedule milestones.
• Ensure all aspects of the project proceed in compliance with cGMP, regulations, and our Company's Quality Management System.
• Focusing on areas such as Qualification and Compliance covering Manufacturing Equipment (isolator, restricted access barrier, incubator, washer, autoclave, formulation vessel, lyophilizer, etc.).
• Review and approval of master batch records, executed records, technical protocols, investigations, change controls, SOPs, validation protocols, technical reports.
• Consults on an as-needed basis with next level manager on more complex decisions.
  
  

Why work with us - At Net2Source, we believe everyone has an opportunity to lead. We see the importance of your perspective and your ability to create value. We want you to fit in—with an inclusive culture, focus on work-life fit and well-being, and a supportive, connected environment; but we also want you to stand out—with opportunities to have a strategic impact, innovate, and take necessary steps to make your mark. We help clients with new skilling, talent strategy, leadership development, employee experience, transformational change management and beyond.

Equal Employment Opportunity Statement

Net2Source is an Equal Opportunity Employer. We believe that no one should be discriminated against because of their differences, such as age, disability, ethnicity, gender, gender identity and expression, religion or sexual orientation. Our rich diversity makes us more innovative, more competitive, and more creative, which helps us better serve our clients and our communities. All employment decisions shall be made without regard to age, race, creed, color, religion, sex, national origin, ancestry, disability status, veteran status, sexual orientation, gender identity or expression, genetic information, marital status, citizenship status or any other basis as protected by federal, state, or local law.

Awards And Accolades

• America's Most Honored Businesses (Top 10%)
• Awarded by USPAAC for Fastest Growing Business in the US
• 12th Fastest Growing Staffing Company in USA by Staffing industry Analysts in the US (2020, 2019, 2020)
• Fastest 50 by NJ Biz (2020, 2019, 2020)
• INC 5000 Fastest growing for 8 consecutive years in a row (only 1.26% companies make it to this list)
• Top 100 by Dallas Business Journal (2020 and 2019)
• Proven Supplier of the Year by Workforce Logiq (2020 and 2019)
• 2019 Spirit of Alliance Award by Agile1
• 2018 Best of the Best Platinum Award by Agile1
• 2018 TechServe Alliance Excellence Awards Winner
• 2017 Best of the Best Gold Award by Agile1(Act1 Group)
  
  

Regards

Recruiter name

Designation

Office: (201) 340-8700 x XXX | Cell: (201) xxx xxxx | Fax: (201) 221-8131| Email: