This position is a key member of the Aziyo Biologics team and as such is involved in executing the Company’s short- term goals and objectives as it relates to operations.
This position is responsible for performing a variety of repetitive and non-repetitive or unique assembly operations for Aziyo products including, but not limited to, receiving, receiving inspection, shipping, inventory control, manufacturing activities as well as environmental monitoring & maintenance. The responsible individual will perform routine data entry in the MRP database, LHR releases, preparation of international shipping documentation, etc. in compliance with internal procedures, FDA quality systems regulations as well as ISO standards.
Position reports to the Director, Operations & Engineering
Essential Duties & Responsibilities
- Issue, track and review Manufacturing Work Order (LHR) documentation for accuracy and component/product traceability.
- Assemble products according to approved operating procedures.
- Perform label printing and final packaging as required to support operations functions.
- Perform self-inspection on all assembly work performed to ensure adherence to workmanship standards.
- Maintain clean and orderly work station.
- Follow all corporate, safety and production operating procedures.
- Perform environmental monitoring including viable & non-viable particulate counting, surface microbial testing as well as review and analysis of data for each test cycle.
- Other duties as required.
Inventory & Distribution:
- Process incoming receiving and inventory transactions in the MRP system.
- Process transactions and documentation associated with product returns.
- Perform periodic cycle counting to monitor inventory levels and report inventory balances for financial reconciliation.
- Prepare and review inspection documentation and perform inspections as needed.
- Prepare international shipments with appropriate documentation in compliance with all applicable export requirements.
- High School Diploma or equivalent.
Experience and Skills
- 1 – 2 years’ experience in manufacturing and/or quality (production, packaging, labeling incoming and shipping, critical systems, etc.) preferred.
- Experience working in regulated work environment preferred – compliance to specifications and procedures as well as FDA QSR’s (21 CFR 820) and ISO 13485.
- Basic computer skills.
- Must be a self-starter and demonstrate a commitment to process improvement.
- Ability to exercise judgement, problem solve and work well with cross-functional teams.
- Excellent organizational skills.
- Service oriented with meticulous attention to detail.
- Works well under pressure with strict deadlines.
- Must have the ability to lift 65 lbs. or more.
- Some operations require bending, standing long hours, pushing and/or pulling objects to a machine or/on a cart.
- Ability to distinguish colors
We are an equal opportunity employer committed to affirmative action and diversity in our workforce – M/F/D/V
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