Senior FDA Mock-Inspection Auditor - GCP/GMP Expert
$4,500 - $5,000 per weekA Medium Corporation
SQA Services is seeking a Senior Auditor in Indianapolis to conduct a 4-day mock FDA Pre-Approval Inspection (PAI). The successful candidate will have direct FDA inspection experience, a strong grasp of Good Clinical Practices (GCP) and Good Manufacturing Practices (GMP), and be proficient in evaluating compliance and reporting findings. This role involves critical assessments to ensure readiness for regulatory inspections and necessitates travel for the audit. The compensation is between $4,500 - $5,000 per week, including reimbursed travel expenses. #J-18808-Ljbffr
$4,500 - $5,000 per week
...SQA Services is seeking a senior auditor with FDA experience for a 4-day mock FDA Pre-Approval Inspection in Indianapolis, Indiana. The ideal candidate will conduct inspections... ...should have a strong background in GCP and GMP operations, and experience with regulatory audits...Senior- ...SQA Services seeks a Senior Auditor in Indianapolis to conduct mock FDA Pre-Approval Inspections. The ideal candidate will have direct experience with... ...particularly in Good Clinical Practices (GCP) and Good Manufacturing Practices (GMP). The role involves assessing...SeniorWeekly payPermanent employment
$4,500 - $5,000 per week
...corrective actions, inspections, remediation, and engineering... ...deploy experienced auditors across the United... ...is seeking a senior auditor with former FDA experience and direct... ...to support a 4-day mock FDA Pre-Approval Inspection... ...risks across GCP and GMP operations . The auditor...SuggestedPermanent employment- ...company headquartered in Indianapolis, Indiana is seeking a Machine Parts Inspector II. In this role, you will perform detailed inspections of a variety of complex machined parts and ensure quality adherence to AS9100 standards. Applicants should have over 6 years of mechanical...Senior
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$90k - $120k
...Job Description: Senior Auditor Location: Indianapolis, IN - Hybrid Compensation: $90,000 - $120,000 (depending on experience) About the Opportunity We are representing a respected regional CPA firm in Indianapolis that is seeking a Senior Auditor to...Senior- ...F. Hoffmann-La Roche AG is looking for a skilled Technical Expert specializing in eDiscovery to join the Roche Digital Technology team in Indianapolis. In this role, you'll act as the main technical link between teams, focusing on ensuring effective eDiscovery processes...Senior
$65.25k - $169.4k
...around the world. Position Overview The Senior / Principal Associate QA API External Manufacturing... ...API shipments. Participate in regulatory inspection preparations with CMs and provide on‑site... ...Life Sciences. Five or more years of GMP manufacturing knowledge and/or experience...SeniorFull timeContract workFlexible hours$66k - $171.6k
...life better for people around the world. The Senior Principal Engineer - Automation... ...the Principal Engineer, as a key technical expert will collaborate with partners within the... ...and business processes required to support GMP operations, and build the site culture. This...SeniorFull timeWork experience placementRemote workFlexible hours$86k
...Senior Auditor Sikich team members have a lot in common while also being part of a rich and varied group of contributors, creating a distinct and thriving culture. Chief among our commonalities is a desire for growth and a shared unity of purpose in our professional...SeniorFull timeContract workWork at officeLocal areaFlexible hours$101k
...Description SupervisorySenior Auditor (US - Alexandria, VA, Columbus, OH, Indianapolis, IN) What to expect when you join Sikich Team members at Sikich have a lot in common while also being part of a rich and varied group of contributors, creating a distinct...SeniorFull timeContract workWork at officeFlexible hours- ...Radiopharmaceutical facility. This position will lead commissioning, qualification, and validation activities, applying broad engineering and GMP knowledge. You will collaborate with teams to ensure the efficacy of validation protocols and drive continuous improvement in...Senior
- ...Swisscom (Schweiz) AG sucht einen Senior Avaloq Consultant in Indiana, USA. Du entwirfst IT-Lösungen auf Avaloq-Plattformen und unterstützt Kunden bei der Weiterentwicklung ihrer Bankensysteme sowie der Integration von FinTech-Lösungen. Der ideale Kandidat hat Erfahrung...SeniorFlexible hours
- ...Documents, international guidelines such as ICH-GCP, and relevant local regulations and that... ...of the study. Ensures the sites are inspection ready at all times. Actively... ...international guidelines ICH-GCP, basic knowledge of GMP/GDP. Good knowledge of relevant local...SeniorLocal areaRemote workFlexible hoursShift work
- A leading compliance firm is seeking a Senior QA Compliance Auditor on a contract-to-hire basis. This role involves leading audit activities to ensure adherence to regulatory standards in a clinical research environment. The ideal candidate will possess a Bachelor's in...SeniorContract work
$100k - $124.95k
...transformation. Qualifications: AES Clean Energy is seeking a highly technical NERC CIP Compliance Senior Technical Auditor to provide leadership, independent oversight, and expert guidance in maintaining continuous compliance with the NERC CIP Standards that support the...SeniorContract workFor contractorsWorldwide- KSM (Katz, Sapper & Miller), located in Indianapolis, seeks an experienced accounting professional to assist in purchase accounting and advisory services. The ideal candidate holds a Bachelor’s degree and has 2-4 years of relevant experience. This role emphasizes collaboration...Senior
$60k - $80k
Tata Consultancy Services is seeking a Storage Subject Matter Expert (SME) in Indianapolis, Indiana. The role requires expertise in L3 administration across Dell EMC platforms and includes responsibilities such as providing technical support for enterprise storage environments...Senior- ...Humana Inc in Indianapolis is seeking a Senior Internal Auditor to drive strategic and financial objectives. You will lead audit engagements and assess the effectiveness of operational processes. The ideal candidate has over 3 years of experience in auditing within a healthcare...Senior
- Closure Systems International Inc is seeking an IT professional in Indianapolis, Indiana. The role involves creating and maintaining SharePoint sites and Power Automate flows, managing Oracle EBS, and participating in project management. The ideal candidate should have...SeniorWork at office
$101k
Position Summary Sikich is seeking a highly motivated and detail-oriented auditing professional with strong leadership and accounting skills. This role is contingent upon award of contract. This position requires an active Secret clearance or the ability to obtain this ...SeniorContract workWork at officeLocal areaFlexible hours- ...Indianapolis, Indiana. The role involves reviewing quality documentation and partnering with manufacturing teams to ensure compliance with GMP regulations. Candidates should possess a Bachelor’s degree in a scientific discipline and have over 8 years of experience in GMP-...Senior
$40 - $55 per hour
...Apex Systems is seeking a Sr. Technical Writer to support a global LabVantage LIMS implementation. You will author and manage GMP documentation including SOPs and validation evidence, utilizing AI tools to enhance document efficiency. This remote role requires 5+ years...SeniorHourly payRemote work- ...R550US The Finish Line USA, Inc. is seeking a Senior Internal Auditor to manage audit fieldwork and enhance operational efficiency. The ideal candidate should hold a Bachelor’s degree in Finance or Accounting, possess professional certifications such as CPA, and have a...Senior
- ...Bristol-Myers Squibb is seeking a Senior Supplier Quality Auditor in Indianapolis. This role involves leading the planning, execution, and reporting of audits for suppliers to ensure compliance with cGMP/GxP regulations. You will work collaboratively in a multidisciplinary...SeniorFlexible hours
$68k - $85k
...Director of Operations Support, this individual will evaluate, inspect, audit, and determine the effectiveness of compliance and store... ...Monro Forward initiatives, DM onboarding, inventory subject matter expert, inventory analysis, safety compliance, building and equipment...Work at officeFlexible hours- ...automated and high-speed packaging line activities within a GMP environment Manage investigations, deviations, CAPAs,... ...Engineering, Technical Services, and Supply Chain teams Ensure inspection readiness for FDA, EMA, and client audits Support defect investigations,...Senior
- Elements Financial Services, LLC is seeking an experienced Underwriter for a hybrid position based in Indianapolis, Indiana. The role requires expertise in underwriting various loan types and strong analytical skills to assess and decide on loan applications within assigned...Senior
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