- Senior
- Escritório em Burleson
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 Lead, Quality Analyst
The Lead, Quality Analyst will perform a variety of tasks under limited supervision, responsibilities include, but are not limited to; controlled documentation issuance, batch record review, verification of manufacturing activities (including operations within production areas), standard operating procedure creation and review, investigations, and implementing corrective and preventive actions. providing quality and compliance related support for the storage, and distribution of healthcare products (biologic, human tissue and medical device products). The Sr Quality Analyst must demonstrate accountability, transparency, and effective communication cross-functionally and within the QA team.
Requirements of the Lead, Quality Analyst
- Bachelor's Degree in a Life Sciences discipline, or related field, along with 5 years of experience in quality assurance within a GxP regulated environment OR 10 years of experience in quality assurance within a GxP regulated environment without a formal degree.
- In-depth knowledge of FDA regulations (21 CFR Part 820, 210/211/1271/1272), cGMP, GDP, and ISO 13485.
- Knowledge of modern quality systems, risk assessment, corrective and preventive action development and execution, and other evolving principles across the global compliance
- Proven ability to multitask, while organizing and prioritizing workload to meet deadlines and corporate objectives in a fast-paced environment
- Self-directed and highly motivated team player
- Proficient in quality systems software, Enterprise Resource Planning software and Microsoft Office Suite.
- Strong analytical, documentation, and problem-solving skills.
- Excellent verbal and written communication.
- Familiarity with ANSI/ASQ Z1.4-2003, c=0 and AQL methodologies
- Experience writing Standard Operating Procedures and Work Instructions
Responsibilities of the Lead, Quality Analyst
The specific duties of the Lead, Quality Analyst include but are not limited to:
- Serves as technical expert and process leader, helping to drive quality strategy with management.
- Performs reviews of production batch records and manufacturing records as part of lot release activities for compliance to procedures, regulations, and Good Documentation practices.
- Collaborate with cross functional teams to ensure timely and compliant product release.
- Initiates and investigates CAPA, Change Management, and Deviation records, ensuring tasks are completed on time.
- Assists teams in problem solving and root cause analysis for associated quality events.
- Completes incoming material inspections, in-process inspections and finished product inspections. Products include Medical Devices, sterile processed Human Tissue-Based Products, unprocessed human tissue, components, supplies and labeling materials.
- Interfaces with colleagues to ensure effective corrective and preventive actions are implemented for any recurring product/process discrepancies.
- Monitors, reviews, and manages Environmental Monitoring Systems (EMS), including alarm response, excursions, calibration verification, testing programs, and periodic reviews.
- Assists in internal and external onsite regulatory audits and inspections to ensure site is inspection ready.
- Identify non-compliance trends and systematic risks for assigned areas of responsibilities and escalate to QA management
- Provides timely, appropriate support and response to the needs of internal and external customers.
- Understands the requirements of Axogen’s Quality Management System, FDA Regulations and various domestic and international standards. Axogen complies with multiple FDA Regulations – Medical Device, Human Cellular, Tissue-Based Products and Biologics/Pharmaceuticals, AATB, ISO 13485, & National Association of Boards of Pharmacy
- Works closely with Management Teams to ensure operations are in compliance with all applicable requirements (Quality Systems, Regulations and Standards).
- Performs the Quality Release of Labeling for all product families including International Labeling.
- Perform product disposition as per deviation and/or complaint investigation outcomes.
- Ability to train and/or mentor newly hired peers as needed.
Location
300 Boone Rd, Burleson, TX 76028
Benefits/Compensation
This position is eligible for an annual bonus.
Benefits offered for this position include Health, Dental, Vision, Matching 401K, Paid Time Off, 9 Paid Holidays + 3 Floating Holidays, Dependent Care Flexible Spending Accounts, Medical Flexible Spending Accounts, Tuition Reimbursement, Paid Parental Leave, Paid Caregiver Leave, Basic Life Insurance, Supplemental Life Insurance, Employee Stock Purchase Plan, and Disability Insurance, as described in more detail in summary plan descriptions.
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.
