Supplier Quality Specialist - Pharmaceutical Manufacturing
SRG
Overview Quality Assurance Specialist - Supplier Quality — Supports high-impact QA and supplier qualification activities. Pharmaceutical Manufacturing. Hybrid in Indianapolis, IN - 2 weeks/month onsite. 12 month contract. Required Qualifications Bachelor's degree in Life Sciences, Engineering, or related scientific/technical field 3-5+ years of experience in a regulated pharmaceutical, biotech, or life sciences environment Direct experience managing quality agreements or similar GxP-controlled documentation Experience working cross-functionally with QA, Procurement, Legal, and Regulatory teams Proven ability to manage multiple concurrent deliverables in a fast-paced environmen t Key Responsibilities Draft, review, and revise quality agreements in alignment with internal SOPs and GxP regulations Manage the full lifecycle of quality agreements, from initiation through negotiation, execution, and closure Partner with internal stakeholders (QA, Procurement, Legal, Regulatory) to resolve open items and obtain approvals Engage with external partners to negotiate terms, respond to redlines, and drive agreements to completion Maintain accurate tracking of agreement status, milestones, and version history within tracking systems Identify and escalate risks or delays that may impact supplier qualification, regulatory compliance, or manufacturing readiness Support continuous improvement initiatives related to quality agreement processes and templates Regulatory Knowledge 21 CFR Parts 210/211 ICH Q7 and Q10 EU GMP (Chapter 7 / Annex 16) Technical Skills Experience with Quality Management Systems (e.g., Veeva Vault, QDocs, or similar) Familiarity with procurement/contract systems (e.g., SAP, Ariba) preferred Proficiency in Microsoft Office (Word, Excel, Outlook, PowerPoint) and collaboration tools Experience with tracking tools (e.g., Smartsheet or equivalent) strongly preferred Impellam Group and its brands are equal-opportunity employers committed to diversity and inclusion. All qualified applicants will receive consideration without regard to race, color, religion, gender, sexual orientation, pregnancy or maternity, national origin, age, disability, veteran status, or any other factor determined to be unlawful under applicable law. We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application, interview process, pre-employment activity, and the performance of crucial job functions. If you require additional disability considerations, modifications, or adjustments please let us know by contacting View email address on click.appcast.io or fill out this form to request accommodations. #J-18808-Ljbffr SRG
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- ...methods, specifications, and quality documentation. Utilize quality... ...3+ years of experience within pharmaceutical, biologics, medical device, or regulated manufacturing environments. Experience supporting... ...expectations. Experience with supplier quality processes including...SuggestedWork at office
- ...document management activities • Utilize quality tools such as Fishbone, FMEA, 5 Why,... ...cross-functionally with Quality, Manufacturing, Engineering, and Operations teams... ...related field • 3+ years of experience in pharmaceutical, biotech, or medical device manufacturing...SuggestedWork at office
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...Quality Assurance Auditor I Colorcon® is a world leader in... ...functional packaging for the pharmaceutical, nutritional, and animal health... ...design, development, and manufacture. Our focus on market... ...as a pharmaceutical supplier of choice. That reputation is...- ...each individual through the lens of their personal health and making high-quality care more accessible and affordable for everyone. To learn more, visit . Job Summary The Quality Control Specialist is responsible for reviewing electronic medical records and conducting...Remote work
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- ...St. Louis, Missouri with distribution, manufacturing and sales offices throughout the US... ...SmartBones®. Job Summary The Quality Specialist at the Noblesville, IN manufacturing plant... ...Control Internal Audit Supplier Corrective Actions Corrective and...
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