Quality Assurance Systems Associate.
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 testing to support product and process evaluation.
The QA Systems Associate role maintains the compliance in the Quality Systems by fulfilling reviewing, evaluating and approving various Quality related data, records and reports.
Position reports to CAPA Process Manager
Essential Duties & Responsibilities
- Quality review of documents including but not limited to logs, records, preventive maintenance and calibration reports for accuracy and correctness of content.
- Manages Non-Conformance Event (NCE) reports by working with the investigators to assess product impact, complete the root cause analysis and identify appropriate corrective and preventive actions as applicable for each NCE.
- Reviews reports as the QA approver from R&D and Engineering groups.
- Coordinating with Donor Services on tasks requiring QA review and approval.
- Investigates and/or collaborates with the investigation of Out Of Specification results and other events requiring investigations.
- Work in a team oriented atmosphere and display courtesy and consideration to peers and staffs.
- Perform special projects, single tasks or other related work as required or requested.
- Responsible for following guidelines for safe working environment and report unsafe conditions to supervisor.
- Development and/or revision of any new or current procedures or forms required to accomplish the above.
Bachelor degree in life sciences, or other related degree preferred.
Experience and Skills
- 2 years of direct experience in the field.
- Experience in an aseptic environment.
- Experience working in a regulated industry.
- Capable of independent lab work and project management.
- Basic computer skills; including proficiency in Microsoft Outlook & Excel.
- Excellent organizational skills, with the ability to handle multiple priorities and deadlines.
- Possess strong written, verbal and interpersonal communication skills.
- Demonstrated experience utilizing critical judgment and analytical skills.
- Solid PC and data entry skills.
- Demonstrated experience working in a team environment, while maintaining cooperative working relationships.
- Demonstrated experience managing multiple projects simultaneously with strong attention to detail.
- Maintains confidentiality of all records and information, which pertains to donors, families, employees, the organization and related areas.
- Works well under pressure with strict deadlines.
- Available and adaptable to working fluctuating schedules, including weeknights, weekends, holidays and overtime as required
- Some operations require bending, standing long hours, pushing and/or pulling objects to a machine or/on a cart.
- Ability to distinguish colors.