BioLab Holdings is a biotechnology company committed to raising the standard of caring by developing, manufacturing, and commercializing breakthrough products with patient care in mind. At the heart of our work is a mission to optimize the standard of wound care through innovations grounded in science, compassion, and collaboration. We support healthcare distributors, providers, and patients worldwide who share our same initiatives to deliver clinical performance and real-world impact.
Position Summary
The Quality Inspector I supports the Quality team by performing routine inspections of amniotic membrane tissue products throughout processing and packaging to ensure compliance with established quality standards and procedures. This role focuses on following defined Standard Operating Procedures (SOPs), accurately documenting inspection results, and escalating issues as identified. The position requires strong attention to detail, reliability, and a willingness to learn within a regulated manufacturing environment.
Essential Functions
Inspection:
- Perform routine incoming inspections of supplies/materials used in manufacturing of amniotic membrane tissue products
- Assist with routine inspections of returned amniotic membrane tissue products, which includes integrity of the sterile barrier under established SOPs.
- Inspect tissue items for packaging accuracy, labeling correctness and verify that tissue packaging and labeling meet documented specifications and quality requirements.
- Conduct visual inspections to identify obvious defects and document all findings on quality documentation
- Escalate inspection findings, discrepancies, or potential quality issues to senior Quality team members or management.
- Assist with ensuring products meet defined acceptance criteria prior to performing final release to finished goods.
- Assist in quarantining amniotic membrane tissue products and/or supplies and releasing when deemed acceptable
Documentation and Reporting:
- Accurately document inspection activities and results in accordance with GMP and internal documentation requirements.
- Maintain clear and complete inspection records to support product traceability.
- Assist with the preparation of inspection-related documentation and reports, as directed.
Compliance and Regulatory Adherence:
- Follow FDA, AATB, and internal regulatory requirements applicable to tissue processing and inspection activities.
- Support audit and inspection readiness by maintaining accurate records and providing documentation upon request.
- Participate in required training to remain compliant with applicable regulations and procedures.
Process Support:
- Follow established quality control processes and tissue handling procedures.
- Identify and report potential quality concerns, deviations, or tissue integrity issues to the Quality team.
- Support corrective and preventive actions (CAPAs) or non-conformance investigations by providing inspection data and documentation.
Training and Development:
- Complete onboarding and ongoing training related to quality inspection procedures, safety protocols, and compliance requirements.
- Learn and apply new or revised SOPs as they are implemented.
- Seek guidance from senior Quality team members to develop inspection skills and regulatory knowledge.
Team Collaboration and Support:
- Work closely with processing, packaging, and shipping teams to ensure product quality is maintained throughout operations.
- Communicate inspection findings clearly and promptly to support timely resolution of issues.
- Assist the Quality team with tasks such as donor chart reviews, complaint support, and other quality-related activities as assigned.
- Perform additional duties as needed to support Quality department objectives.
This job description is not intended to be an exhaustive list of all duties, responsibilities, or
qualifiations associated with the job. Other duties may be assigned.
Minimum Qualifications
Education:
- High school diploma or equivalent required. A degree in biological sciences, medical technology, or a related field is preferred.
Experience:
- Familiarity with tissue processing, especially amniotic membrane or other human tissue, is an asset.
Certifications:
None required
Knowledge, Skills, and Abilities
- Strong attention to detail with the ability to identify quality issues and defects in tissue products.
- Basic computer skills, ERP experience is a plus but not required.
- Strong communication and collaboration skills.
Physical Requirements
- Ability to sit, stand, and walk for extended periods throughout the workday.
- Frequent use of hands and fingers to handle, inspect, manipulate, and package small tissue products and related materials.
- Ability to visually inspect tissue products, labels, packaging components, and documentation with a high degree of accuracy and attention to detail.
- Ability to distinguish colors, identify defects, and recognize inconsistencies in product appearance, labeling, and packaging.
- Frequent use of a computer and standard office equipment, including keyboards, monitors, scanners, and printers.
- Ability to reach, bend, stoop, kneel, and perform repetitive motions as required during inspection and documentation activities.
- Ability to lift, carry, push, and pull materials and supplies weighing up to 25 pounds occasionally and up to 10 pounds frequently.
- Ability to work in controlled manufacturing, laboratory, cleanroom, and warehouse environments while adhering to gowning, personal protective equipment (PPE), and safety requirements.
- Ability to wear required PPE, including gloves, gowns, masks, hair coverings, and safety glasses, for extended periods.
- Ability to maintain focus and accuracy while performing repetitive inspection and documentation tasks.
- Ability to communicate effectively with team members regarding quality findings, discrepancies, and corrective actions.
Work Environment
Employees in this role may be exposed to a variety of environmental, activity-related, and ergonomic hazards throughout the workday. Environmental risks include potential spills, weather-related conditions, inadequate ventilation, exposure to extreme heat or cold, poor housekeeping, chemical exposure, and slip, trip, and fall hazards. Activity-related hazards may involve working around burn or heat sources, compressed gases, electrical cords and tools, energized equipment, and possible exposure to contagious diseases or other unforeseen risks. Ergonomic hazards are also present, including lifting, awkward postures, repetitive motions, and prolonged periods of sitting or standing. Specific job tasks such as sitting at a workstation for extended periods can lead to back, shoulder, hand, arm injuries, and eye strain, while prolonged standing may result in strains, sprains, and leg or knee injuries. Walking throughout the building introduces the risk of slips, trips, falls, and strains, particularly if walkways are obstructed or wet. Additionally, cleaning up spills can pose hazards such as slips, trips, strains, and potential exposure to bloodborne pathogens. Overall, employees must remain aware of these hazards to reduce the risk of injury in the workplace.
Travel Requirements
None
What we offer:
Looking for a company to work for can be a daunting task, but we believe that we stand out from the rest. Our company offers a positive and inclusive work environment, opportunities for growth and development, and a commitment to work-life balance. Join us and become part of a team that values your contributions and invests in your success.
Employment Statement
The Company is an equal opportunity employer and complies with all applicable federal, state, and local employment laws. Employment decisions are made without regard to race, color, religion, sex, national origin, age, disability, genetic information, veteran status, sexual orientation, gender identity, or any other status protected by applicable federal, state, or local law.
In accordance with the Americans with Disabilities Act, reasonable accommodations may be made to enable qualified individuals with disabilities to perform essential job functions or participate in the application process. Applicants needing accommodation should contact Human Resources.
Applicants must be legally authorized to work in the United States at the time of hire. The Company participates in employment eligibility verification as required by law.
The salary range for this position represents the anticipated compensation at the time of posting and may vary based on experience, qualifications, and geographic location where applicable.
Employment with the Company is at-will, meaning that either the employee or the Company may terminate employment at any time, with or without cause or notice, subject to applicable law.
