Overview
Product Quality Specialist Jobs in Lutz, FL at Not Your Mother’s
Axogen is committed to building and maintaining a strong and gratifying company culture that fosters professional growth. Our hands-on and personal approach makes transitioning to a new job a seamless and enjoyable process. Most benefits are effective on day one!
Axogen is an equal opportunity employer and does not discriminate against applicants on the basis of race, color, creed, religion, ancestry, age, sex, marital status, national origin, disability or veteran status.
Why you’ll love working at Axogen:
Friendly, open, and fun team culture that values unique perspectives
Company-wide dedication to profoundly impacting patients’ lives
Comprehensive, high-quality benefits package effective on date of hire
Educational assistance available for all employees
Matching 401(k) retirement plan
Paid holidays, including floating holidays, to be used at your discretion
Employee Stock Purchase Plan
Referral incentive program
Axogen Mission and Business Purpose
Our business purpose is to restore health and improve quality of life by making restoration of peripheral nerve function an expected standard of care. We aim to lead the markets we serve by always requiring the solutions we offer patients and caregivers provide an improved benefit-to-risk profile as compared to existing standards of care. To ensure we deliver improved benefit-to-risk solutions, we will guide and expect the market and design requirement specifications underlying our engineering, business development, and clinical research activities, objectively target advancements in standards of care.
Job Summary of the Sr. Clinical Quality Assurance Specialist
Responsible for leading Clinical Quality Assurance (CQA) activities for assigned clinical development programs, including the management of audits, quality issues and investigations, and inspections. This position requires a depth of understanding and experience in GCP and compliance, leadership, communication skills, and business acumen to conduct responsibilities with minimal supervision. This position will liaise and interface with internal and external stakeholders in order to assess and support compliance with international guidelines (e.g. ICH-GCP, GCLP, and GLP), applicable international and local regulations, and corporate quality standards in the clinical development field. It will also support the maintenance, execution, and improvement of a risk-based Clinical Quality Audit Program with focus on Early Clinical and Clinical Development.
Requirements of the Sr. Clinical Quality Assurance Specialist
Bachelor’s degree required, Science or technical degree preferred
Minimum 8 years of directly related experience in Biotech or Pharma Clinical Quality Assurance
In-depth experience with ICH GCP E6 Guideline
Minimum 4 years’ GCP auditing experience required; GCP Auditor Certification is an asset
Clinical Study Management or monitoring experience is an asset
GLP or GCLP Experience is a solid asset (21CFR Part 11, 21 CFR Part 58 and OECD Principles)
Solid knowledge of modern quality systems, risk assessment, corrective and preventive action development and execution, and other evolving principles across the global compliance
Excellent written and verbal communication skills; the ability to effectively write and edit comprehensive documents for a variety of audiences
Excellent interpersonal skills with a proven track record of building and maintaining strong relationships with internal and external stakeholders
Proven ability to work effectively as a team member, including cross-functional teams
Proven ability to multitask, to organize and prioritize workload to meet deadlines and corporate objectives in a fast-paced environment
Proven organizational skills and attention to detail with a focus on accuracy and quality
Self-directed and highly motivated team player with solid organizational capabilities
Ability to travel 30 to 40%
Responsibilities of the Sr. Clinical Quality Assurance Specialist
The specific duties of the Sr. Clinical Quality Assurance Associate include but are not limited to:
Provide professional expertise and guidance on Good Clinical Practice (GCP) and applicable regulations to clinical development teams to proactively identify compliance issues/risks and recommend mitigations
Liaise with various Axogen Clinical functions and external parties including contract auditors and investigator sites to promote a high level of quality and consistency across and within programs; develop the risk-based audit and compliance strategy for assigned programs; assist project teams in implementing corrective and preventive actions; and enable teams to be inspection ready, in support of a culture of sustainable compliance
Manage domestic and international audits of sites, documents, databases, vendors or internal systems in compliance with GCP and Axogen policies and procedures; assess impact of audit findings on subject safety, data integrity, and business operations. Audits conducted require advanced auditing skills and may involve technically complex assignments, including audits of high-risk studies/vendors
Support the maintenance, execution, and improvement of a risk-based Clinical Quality Audit Program with focus on Early Clinical and Clinical Development
Develop, review and issue of Audit Reports outlining the findings categorized according to level of risk/s and CAPA recommendations
Review and approve deviations, change controls, and CAPAs
Manage individual CAPAs resulting from audits and inspections to ensure issues are thoroughly evaluated (including a risk assessment, root cause analysis and effectiveness measures) and identified actions are addressed and closed in a timely manner
Directly follow-up on observations resulting from audits of clinical suppliers, clinical sites, and internal audits and oversee timely resolution
Identify non-compliance trends and systematic risks for assigned areas of responsibilities and escalate to senior QA management
Create and revise of GCP-compliant Clinical Research SOPs
Develop and provide routine and as needed GCP training to staff
Serve as the primary point of QA contact for staff of the Clinical Organization ensuring the timely communication of quality risk and compliance as related to GCP/GCLP/GLP and Quality
Support the conduct of pre-inspections, mock-inspections and related follow-up activities, and review of inspection requested information
Other duties as assigned
Location
111 West Oak Ave., Tampa, FL 33602
#LI-AC1
Benefits/Compensation
Axogen follows healthcare system guidelines with respect to credentialing, vaccinations and other employment/compliance related requirements, as well as CDC guidance. Axogen reserves the right to amend its policies from time to time in its sole discretion.
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Title: Product Quality Specialist
Company: Not Your Mother’s
Location: Lutz, FL
