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axogen · 1 day ago

Quality Analyst - 2nd Shift

Vandalia, OH

Full-time

Onsite

New Grad, Entry Level

$57K/yr - $71K/yr

0+ years exp

Axogen is dedicated to restoring health and improving quality of life through advanced medical solutions. The Quality Analyst is responsible for performing quality control inspections and ensuring compliance with FDA and ISO regulations while managing non-conforming materials and products.

BiotechnologyMedicalMedical Device

Culture & Values

H1B Sponsor Likely

Responsibilities

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

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

Maintains 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 hosting of onsite regulatory audits and inspections

Qualification

FDA regulationsQuality System elementsMedical Device experienceANSI/ASQ Z1.4-2003Microsoft ExcelStandard Operating ProceduresWork InstructionsCAPANon-Conforming ReportsDeviations

Required

Able to work 3:00 pm - 11:30 pm, Monday - Friday

High School Diploma and minimum of 0-2 years of relevant industry experience within a Medical Device, Pharmaceutical, or Tissue commercial organization

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

Preferred

Bachelor's Degree in a Life Science discipline, engineering, or in a related field

Familiarity with ANSI/ASQ Z1.4-2003, c=0 and AQL methodologies

Experience in an FDA-regulated environment, particularly medical device, human tissue or pharmaceutical manufacturing

Benefits

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

Disability Insurance

Company

axogen

AxoGen is a biotech company developing treatment options for the reconstruction and repair of peripheral nerve injuries.

Founded in 2002

Alachua, Florida, USA

201-500 employees

http://www.axogeninc.com

H1B Sponsorship

axogen has a track record of offering H1B sponsorships. Please note that this does not guarantee sponsorship for this specific role. Below presents additional info for your reference. (Data Powered by US Department of Labor)

Distribution of Different Job Fields Receiving Sponsorship

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Trends of Total Sponsorships

2024 (1)

2020 (1)