Quality Assurance Specialist

Tiger BioSciences; Conshohocken (Montgomery County); On-site; USD 60,000 - 90,000; Full time

Job summary

Tiger BioSciences is seeking a Quality Assurance Specialist to ensure all products and QC processes meet established requirements. You will review QC records, inspect HCT/P products, and initiate quality events in a regulated environment.

The role requires the ability to work independently or in a team, with strong attention to detail, communication, and ethics. Some after-hours flexibility and collaboration on audits are expected.

Qualifications

• Associate degree in a biological science, engineering, or related field is required.
• Bachelor’s degree in a biological science, engineering, or related field is preferred.
• Clearance of favorable background investigation required.

Responsibilities

• Review quality control records including equipment cleaning/maintenance, environmental monitoring, and supply inspections.
• Inspect HCT/P products per SOP and regulatory requirements.
• Sort and segregate acceptable and unacceptable HCT/P.
• Identify and initiate quality events.
• Communicate inspection or quality control issues to management when necessary.
• Support internal/external audits.
• Maintain knowledge of FDA 21 CFR 1271, FDA 21 CFR 820, AATB Standards, ISO Standards, cGMP/CGTP, and internal policies.
• Maintain attendance and punctuality; ensure completion of tasks within timeframes.
• Flexibility to work outside normal hours to support business needs.
• Perform other duties as assigned.

Skills

Attention to detail

Teamwork

Written communication

Ethics

Leadership

Multitasking

Project management

Microsoft Office

Education

Associate degree in biological science/engineering/related

Bachelor’s degree in biological science/engineering/related (preferred)

Tools

Microsoft Office

Job description

Purpose

The Quality Assurance Specialist is responsible for ensuring all products and quality control processes meet established quality requirements.

Responsibilities

• Review quality control records to include equipment cleaning/maintenance, environmental monitoring, and supply inspections.
• Inspect HCT/P products in accordance with standard operating procedures and regulatory
• Sort and segregate acceptable and unacceptable HCT/P
• Identify and initiate quality events.
• Communicate and escape inspection or quality control issues to Management when necessary.
• Support internal/external audits.
• Maintain a working knowledge of FDA 21 CFR 1271, FDA 21 CFR 820, AATB Standards, ISO Standards, cGMP/CGTP, other relevant regulations/standards, and internal organizational policies and standard operating procedures.
• Maintain acceptable attendance and punctuality for scheduled work hours and meetings. Ensure completion of assigned tasks and responsibilities within defined timeframes.
• Flexibility to work outside of normal business hours during weekdays or weekends with reasonable advance notice to support business/operational needs when necessary.
• Perform other duties as assigned.

Skills

• Ability to work independently and in a team environment.
• Excellent attention to detail and organization.
• Excellent written and verbal communication.
• Highest level of ethics and integrity.
• Ability to lead and motivate the right behaviors.
• Ability to multi-task and work in a fast-paced environment.
• Strong technical writing.
• Effective project management.
• Proficiency in Microsoft Office.

Qualifications/Requirements

• Associate degree (or 60 hours from an accredited college or university) in a biological science, engineering, or related field required.
• Bachelor's degree in a biological science, engineering, or related field preferred.
• At least 0-2 years of experience in an FDA regulated environment for HCT/Ps, medical devices, pharmaceuticals, and/or related field preferred.
• Additional relevant work experience may be substituted for the degree requirement on a year-for-year basis.
• Clearance of favorable background investigation required.