Associate I, Production SystemsBioTissue
Job Summary
About BioTissue & our Culture
At BioTissue, we transform the gift of life by sharing miracles. We are a diverse community, where talent and teamwork are core to who we are. Here, you are EMPOWERED to do the work you love, be yourself, and make an impact. Resilient and committed to our vision, we embrace challenges, celebrate courage, and take great pride in our work to create life-changing products. Purpose led us here. Passion and legacy keep us going.
Position Summary
Associate I, Production Systems supports manufacturing operations by preparing materials, documentation, equipment, and production support activities in a regulated GMP environment. This role follows approved procedures to support safe, compliant, and efficient processing of HCT/P and related products. The position contributes to Safety, Quality, Delivery, and Cost performance by maintaining organized, audit-ready work areas; supporting right-first-time documentation; preparing materials and records for scheduled production; reducing waste and rework; and escalating risks in a timely manner. This position reports to the Lead Associate, Manufacturing and provides a foundation for progression to Associate II and Associate III roles.
Essential Duties & Responsibilities
- Perform routine inventory checks of production materials, supplies, and consumables; communicate shortages, risks, or restock needs.
- Prepare processing carts, raw materials, documentation packets, labels, tools, and supplies in accordance with the production schedule and approved procedures.
- Support Safety initiatives by following PPE, gowning, hygiene, ergonomic, chemical handling, biohazard waste, 6S, and housekeeping requirements.
- Identify and report unsafe conditions, hazards, near misses, equipment concerns, or facility issues in a timely manner.
- Support Quality initiatives by following SOPs, work instructions, cGMP, GTP, GDP, ISO, and aseptic technique requirements.
- Review assigned work for accuracy prior to handoff and escalate documentation, material, process, or potential deviation concerns.
- Support Delivery initiatives by completing assigned tasks on time, preparing materials and records in advance, and communicating barriers to schedule execution.
- Support Cost initiatives by using materials responsibly, minimizing scrap and rework, preventing documentation errors, and identifying opportunities to improve flow.
- Clean, package, stage, and submit reusable instruments, equipment, and materials for sterilization or processing support.
- Pack, organize, label, and stage final product requiring sterilization, quarantine, storage, or transfer to Supply Chain.
- Transfer, thaw, stage, or handle placental tissue and related materials while maintaining product identification, traceability, and integrity.
- Create, stamp, organize, and prepare Batch Production Records, logs, labels, requisitions, work orders, and other GMP documentation.
- Complete requisitions for quality control samples and submit samples to the designated laboratory as required.
- Complete accurate, legible, and timely documentation, including batch records, cleaning logs, equipment logs, inventory forms, and system entries.
- Participate in daily huddles, shift handoffs, Tier 1 discussions, training activities, metric awareness, and continuous improvement activities as assigned.
- Perform administrative and production support duties, including filing, copying, scanning, archiving, record organization, label preparation, and handling confidential documents.
Skills & Abilities
- Strong attention to detail and ability to follow approved procedures, documentation practices, and quality expectations.
- Ability to work safely in a regulated manufacturing, laboratory, or cleanroom environment.
- Awareness of Safety, Quality, Delivery, and Cost priorities, with the ability to recognize risks and communicate issues promptly.
- Good verbal and written communication skills, including accurate task status updates and timely escalation of concerns.
- Ability to prioritize assigned tasks and adapt to changing production needs.
- Working knowledge of inventory control, material staging, documentation handling, and production support practices preferred.
- Ability to support 6S, visual management, daily huddles, waste reduction, right-first-time documentation, and continuous improvement activities.
- Proficiency with Microsoft Office applications, including Excel, Word, PowerPoint, and Outlook; familiarity with production, quality, or inventory systems preferred.
- Demonstrated willingness to learn, accept feedback, develop technical skills, and progress toward Associate II and Associate III expectations.
Position Expertise/Qualifications
- 1-year inventory control and stocking, required
- 1-year administrative support work required
- 1-year previous work experience in a GMP environment, preferred.
Physical Requirements
- Sedentary work that generally requires sitting and/or standing
- Ability to lift 25lbs
Total Rewards
At BioTissue, we believe our people are our greatest asset. We offer a comprehensive Total Rewards package designed to support employees' health, financial wellbeing, professional growth, and work-life balance.
Our benefits may include:
- Medical, Dental, and Vision Insurance
- Health Savings Account (HSA) and Flexible Spending Accounts (FSA)
- 401(k) Retirement Savings Plan
- Company-Paid Basic Life and AD&D Insurance
- Voluntary Life and AD&D Insurance
- Short-Term and Long-Term Disability Coverage
- Employee Assistance Program (EAP)
- Legal and Identity Protection Benefits
- Pet Insurance
- Paid Time Off and Company Holidays
- Paid Parental and Birthing Leave
- Family and Medical Leave (FMLA), where applicable
- Tuition Reimbursement and Professional Development Support
- Performance-Based Incentive Opportunities
- Equity or Stock Programs, where applicable
Benefits eligibility and offerings may vary based on position, location, and employment status.
ADA Statement
BioTissue is committed to providing reasonable accommodations to qualified individuals with disabilities throughout the hiring process and employment lifecycle. If you require assistance or accommodation to participate in the application process or perform the essential functions of a position, please contact us to discuss your needs.
Qualified applicants with disabilities will be considered for employment and may be eligible to perform the essential functions of the position with or without reasonable accommodation.
Equal Employment Opportunity
BioTissue is committed to fostering a workplace where everyone feels valued, respected, and empowered to contribute. We welcome applicants from diverse backgrounds and experiences and are proud to be an Equal Opportunity Employer. Employment decisions are based on qualifications, merit, and business needs, without regard to any legally protected characteristic.
