Quality Analyst - 3rd Shift
Axogen, Inc.

Job Info

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Axogen is committed to building and maintaining a strong and gratifying company culture that fosters a work-life balance and 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 the leading company revolutionizing the science of nerve repair. We are passionate about helping to restore function and quality of life to patients with physical damage or discontinuity to peripheral nerves.

Contribute to positively impacting lives while working for a company that respects, recognizes, and values all team members!

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
• Flexible working hours
• Paid holidays, including floating holidays, to be used at your discretion
• Employee Stock Purchase Plan
• Referral incentive program

If you want to see how you can impact lives at Axogen, take a look at these inspiring patient stories: https://www.axogeninc.com/patient-stories/

Axogen is hiring for a 3rd shift Quality Analyst in Dayton, OH!

Job Summary of the Quality Analyst

The Quality Analyst is responsible for providing quality on the floor oversight to first, second, or third shift. In this role, they will be responsible for printing batch record and other forms as needed, providing quality oversight and training to operators, performing on the floor review, performing quality control (QC) inspection and disposition of materials and products according to specifications, and performing final batch record review and product release activities.

The Quality Analyst is responsible for following all Axogen policies and procedures to ensure compliance with applicable with FDA, state OSHA and ISO regs and standards. Employees within this role will performs a variety of tasks under limited supervision.

Requirements of the Quality Analyst

• Bachelor's Degree in an Engineering, Life Science discipline and/or in a related field
• Minimum of 0-2 years of relevant industry experience within a Medical Device, Pharmaceutical, or Tissue commercial organization.
• Experience in an FDA-regulated environment, particularly medical device, human tissue or pharmaceutical manufacturing preferred.
• Experience with Microsoft Excel
• Experience writing Standard Operating Procedures and Work Instructions
• Experience with Quality System elements for CAPA, Non-Conforming Reports (NCRs) and Deviations.
• Ability to work 3rd shift, Mon - Fri (11-730am)

Responsibilities of the Quality Analyst

The specific duties of the Quality Analyst include but are not limited to:

• Performs reviews of batch production records and manufacturing records as part of lot release activities.
• Coordinates and tracks CAPA, NCR and Deviation records, ensuring tasks are completed on time.
• Coordinates and tracks the site environmental monitoring (EM) testing program.
• Assists teams in coordination of problem solving and root cause analysis for associated quality events.
• Ensures the development, review, and release of quarterly EM trending reports; Assures significant trends are immediately brought to management attention.
• Provides input based on knowledge and experience with batch release requirements.
• Provides QMS Operations related support to all CGMP departments.
• Performs Quality Control activities at AxoGen's processing or distribution sites. The Quality Analyst will be
• responsible for 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.
• The Quality Analyst will maintain accurate and complete records of Quality Control activities, following Good Documentation Practices.
• Provides support related to gowning qualification and training.
• Ensures timely issuance, review, and approval of Microbiology and EM testing results.
• Interfaces with colleagues to ensure effective corrective and preventive actions are implemented for any recurring product/process discrepancies.
• Assists in the review and approval of equipment qualifications.
• Assists in the review of Calibration and Preventative Maintenance reviews.
• Assists in hosing of onsite regulatory audits and inspections.
• Knowledge of current Good Manufacturing Practices (cGMP) and relevant regulatory standards, guidelines and regulations, both in the US and OUS for tissue, Medical Devices and/or Biologics
• Knowledge of statistical sampling and analysis.
• Knowledge of Root Cause Analysis (RCA) methodologies.
• Knowledge of current global initiatives, including Quality by Design, Process Validation, and Data Integrity
• Knowledge of biologics or pharmaceutical batch review & release
• Skill in oral and written communication.
• Skill in organizational techniques and practices.
• Skill in interpersonal and team building techniques.
• Ability to proficiently use MS Office Suite, including Microsoft Visio and Project.
• Ability to exercise creativity and demonstrate good judgment
• Ability to work independently, analyze and work with attention to detail, process and prioritize sensitive complex information and problem solve.
• Ability to set and manage priorities and schedule activities accordingly.
• Travel Requirement: 10%

Location

349 S. Mainstreet, Dayton, OH 45402

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Compensation/Benefits

This position is eligible for 3rd shift differential pay.

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 + 2 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, Equity, and Disability insurance, as described in more detail in summary plan descriptions.

Salary Range

$51,912-$64,890 USD

Axogen is on a hybrid work schedule at some facilities, with 3 days in office and 2 days remote.

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.

If you know someone who would be a great candidate for this position, or any others, just copy and send this link! https://grnh.se/cc84962d2us

This job has expired.