Quality Assurance Specialist - Quality Agreements
Lebanon, Maine, United States of America
Contract
1 week ago
Key skills
AIArtificial IntelligenceVaultVersion ControlSAPCommunicationCollaboration
About this role
Description:
Hybrid onsite 2 weeks per month in Lebanon, IN
Our client seeks a Quality Assurance Specialist to manage the end-to-end lifecycle of quality agreements across suppliers, service providers, contract manufacturers, and laboratories in a regulated pharmaceutical setting. The specialist will draft, negotiate, execute, and track agreements while coordinating with QA, Procurement, Legal, and Regulatory Affairs to maintain timelines and compliance. The role will support supplier qualification, manufacturing readiness, and continuous improvement of templates and workflows. The position reports to the Associate Director of QA.
Due to client requirements, applicants must be willing and able to work on a w2 basis. For our w2 consultants, we offer a great benefits package that includes Medical, Dental, and Vision benefits, 401k with company matching, and life insurance.
Rate: $75.00 to $90.00/hr. w2
Responsibilities:
Experience Requirements:
Education Requirements:
Recruitment Transparency Notice
Eliassen Group values transparency in our recruitment practices. Please be advised that Eliassen Group utilizes artificial intelligence (AI) tools as part of its initial application screening and hiring process. You may receive email and SMS notifications from the Eliassen Virtual Recruiting Team (, ) inviting you to complete a brief voice screening as part of your application process. These tools assist our hiring teams in different ways, including but not limited to, assistance in reviewing application materials to help identify candidates whose qualifications most closely match the requirements of the position. All AI-assisted evaluations and responses are reviewed by human recruiters before any hiring decisions are made. The use of AI in our process is intended to support fairness, efficiency, and consistency, and Eliassen Group takes measures to prevent bias or discrimination in connection with its hiring practices. By proceeding, you acknowledge, agree, and consent to Eliassen Group's use of these tools, including AI tools, as part of the application and hiring process.
Skills, experience, and other compensable factors will be considered when determining pay rate. The pay range provided in this posting reflects a W2 hourly rate; other employment options may be available that may result in pay outside of the provided range.
W2 employees of Eliassen Group who are regularly scheduled to work 30 or more hours per week are eligible for the following benefits: medical (choice of 3 plans), dental, vision, pre-tax accounts, other voluntary benefits including life and disability insurance, 401(k) with match, and sick time if required by law in the worked-in state/locality.
If anyone reaches out to you about an open position connected with Eliassen Group, please ensure that you are working directly with us by confirming the following:
When you work with Eliassen Group, all email communication will come from an Eliassen.com address, never Gmail, Yahoo, etc.
Eliassen Group will never ask you for personal information (home address, bank account, or check routing number) until you have worked with someone clearly associated with Eliassen Group.
If you have any indication of fraudulent activity, please contact .
About Eliassen Group:
Eliassen Group is a strategic consulting firm that helps organizations reach further and achieve more through our technology, business advisory, and life sciences solutions. For nearly 40 years, we have combined exceptional people, deep domain expertise, and intelligent capabilities to expand our clients' capacity and accelerate meaningful outcomes. We are driven by a purpose to positively impact the lives of our employees, clients, consultants, and the communities we serve.
Eliassen is committed to building a diverse and inclusive team from a variety of backgrounds, perspectives, and skills. We are an Equal Opportunity and Affirmative Action Employer and all employment decisions are based on merit, performance, and business needs. Eliassen does not discriminate on the basis of race, color, gender identity or expression, sexual preference or orientation, sex (including pregnancy, childbirth, and related medical conditions), marital status, creed, religion, physical or mental disability, genetic information, military or veteran status, age, ancestry, national origin, citizenship status, prohibited criminal record inquiries of applicants and employees, or any other category protected by federal, state, or local laws.
Don't miss out on our referral program! If we hire a candidate that you refer us to then you can be eligible for a $1,000 referral check!
Hybrid onsite 2 weeks per month in Lebanon, IN
Our client seeks a Quality Assurance Specialist to manage the end-to-end lifecycle of quality agreements across suppliers, service providers, contract manufacturers, and laboratories in a regulated pharmaceutical setting. The specialist will draft, negotiate, execute, and track agreements while coordinating with QA, Procurement, Legal, and Regulatory Affairs to maintain timelines and compliance. The role will support supplier qualification, manufacturing readiness, and continuous improvement of templates and workflows. The position reports to the Associate Director of QA.
Due to client requirements, applicants must be willing and able to work on a w2 basis. For our w2 consultants, we offer a great benefits package that includes Medical, Dental, and Vision benefits, 401k with company matching, and life insurance.
Rate: $75.00 to $90.00/hr. w2
Responsibilities:
- Draft, review, revise, negotiate, and execute quality agreements for external partners including suppliers, service providers, contract manufacturers, and contract laboratories.
- Manage the full lifecycle of quality agreements from initiation through closure while ensuring adherence to program timelines and supplier qualification milestones.
- Collaborate cross-functionally with QA, Procurement, Legal, Regulatory Affairs, and external partners to align on agreement language, resolve redlines, and obtain required approvals.
- Maintain accurate documentation, version control, and status tracking of quality agreements within applicable quality management systems and workflow tools.
- Identify, communicate, and escalate risks or delays that may impact supplier qualification, manufacturing readiness, or regulatory compliance.
- Support continuous improvement initiatives related to quality agreement templates, workflows, and process standardization.
- Assist with additional QA and compliance activities as needed to support broader organizational priorities.
Experience Requirements:
- Minimum 3 to 5 years in a regulated pharmaceutical, biotechnology, or life sciences environment supporting Quality Assurance, Supplier Quality, Compliance, or Quality Systems functions.
- Demonstrated experience drafting, reviewing, negotiating, and managing quality agreements or similar GxP-controlled documentation.
- Working knowledge of GMP regulations including 21 CFR Parts 210 and 211, ICH Q7, ICH Q10, EU GMP Chapter 7 and Annex 16, and FDA guidance related to contract manufacturing and quality agreements.
- Experience with quality management and document control systems such as QDocs and Veeva Vault.
- Familiarity with USP and ICH Q6A/Q6B standards (preferred).
- Familiarity with procurement and contract management systems such as SAP or Ariba (preferred).
- Proficiency with Microsoft Office Suite, Adobe Acrobat, Microsoft Teams, and workflow tracking tools such as Smartsheet.
- Strong cross-functional collaboration experience with QA, Procurement, Legal, and Regulatory Affairs.
- Proven ability to manage multiple concurrent agreements, deliverables, and competing priorities in a deadline-driven environment.
Education Requirements:
- Bachelor's degree in Life Sciences, Chemistry, Pharmacy, Biochemistry, Engineering, or a relevant scientific or technical discipline.
Recruitment Transparency Notice
Eliassen Group values transparency in our recruitment practices. Please be advised that Eliassen Group utilizes artificial intelligence (AI) tools as part of its initial application screening and hiring process. You may receive email and SMS notifications from the Eliassen Virtual Recruiting Team (, ) inviting you to complete a brief voice screening as part of your application process. These tools assist our hiring teams in different ways, including but not limited to, assistance in reviewing application materials to help identify candidates whose qualifications most closely match the requirements of the position. All AI-assisted evaluations and responses are reviewed by human recruiters before any hiring decisions are made. The use of AI in our process is intended to support fairness, efficiency, and consistency, and Eliassen Group takes measures to prevent bias or discrimination in connection with its hiring practices. By proceeding, you acknowledge, agree, and consent to Eliassen Group's use of these tools, including AI tools, as part of the application and hiring process.
Skills, experience, and other compensable factors will be considered when determining pay rate. The pay range provided in this posting reflects a W2 hourly rate; other employment options may be available that may result in pay outside of the provided range.
W2 employees of Eliassen Group who are regularly scheduled to work 30 or more hours per week are eligible for the following benefits: medical (choice of 3 plans), dental, vision, pre-tax accounts, other voluntary benefits including life and disability insurance, 401(k) with match, and sick time if required by law in the worked-in state/locality.
If anyone reaches out to you about an open position connected with Eliassen Group, please ensure that you are working directly with us by confirming the following:
When you work with Eliassen Group, all email communication will come from an Eliassen.com address, never Gmail, Yahoo, etc.
Eliassen Group will never ask you for personal information (home address, bank account, or check routing number) until you have worked with someone clearly associated with Eliassen Group.
If you have any indication of fraudulent activity, please contact .
About Eliassen Group:
Eliassen Group is a strategic consulting firm that helps organizations reach further and achieve more through our technology, business advisory, and life sciences solutions. For nearly 40 years, we have combined exceptional people, deep domain expertise, and intelligent capabilities to expand our clients' capacity and accelerate meaningful outcomes. We are driven by a purpose to positively impact the lives of our employees, clients, consultants, and the communities we serve.
Eliassen is committed to building a diverse and inclusive team from a variety of backgrounds, perspectives, and skills. We are an Equal Opportunity and Affirmative Action Employer and all employment decisions are based on merit, performance, and business needs. Eliassen does not discriminate on the basis of race, color, gender identity or expression, sexual preference or orientation, sex (including pregnancy, childbirth, and related medical conditions), marital status, creed, religion, physical or mental disability, genetic information, military or veteran status, age, ancestry, national origin, citizenship status, prohibited criminal record inquiries of applicants and employees, or any other category protected by federal, state, or local laws.
Don't miss out on our referral program! If we hire a candidate that you refer us to then you can be eligible for a $1,000 referral check!