Specialist II, QA Operations

Biontech Ag - Gaithersburg, MD

Part-time - Mid Level

Gaithersburg, MD

Professional, Scientific, and Technical Services

About the position

As a Specialist II in QA Operations at BioNTech, you will play a crucial role in ensuring the quality and compliance of our manufacturing processes. Your primary responsibility will be to provide Quality Assurance support across various stages of production, including raw materials, in-process materials, and final products. You will be actively involved in resolving manufacturing issues, ensuring adherence to Good Manufacturing Practices (GMP), and maintaining the integrity of our operations in cleanroom and laboratory environments. Your expertise will be essential in conducting quality walk-throughs, performing batch documentation reviews, and overseeing the packaging and shipping processes. You will also support the deviation and corrective action systems, ensuring timely investigations and implementation of corrective measures. This position requires a proactive approach to identifying compliance risks and collaborating with various departments to uphold our commitment to quality and safety in the development of immunotherapies. In this role, you will be expected to engage in hands-on QA support, providing oversight during tech transfers and manufacturing operations. You will be responsible for the disposition of incoming materials, including patient apheresis material, and ensuring that all products are manufactured in compliance with regulatory guidelines. Your contributions will extend to training new hires and supporting the tracking of site quality metrics, which are vital for continuous improvement. You will be part of a dynamic team that values scientific rigor, innovation, and a passion for improving health outcomes worldwide. Your ability to communicate effectively and work independently will be key to your success in this fast-paced environment.

Responsibilities

• Provide Quality Assurance support resolving raw material, in-process material and/or product, final product, environmental, analytical, facility and equipment manufacturing issues.
• Provide Quality Assurance input and oversight in resolving tech transfer, manufacturing and warehouse operations-related issues.
• Provide on-the-floor QA support in GMP cleanroom and laboratory environments and support to ensure compliance to GMP regulations throughout those areas.
• Perform quality walk-throughs and process observations.
• Disposition incoming materials.
• Perform receipt and disposition of incoming patient apheresis material.
• Perform issuance verification of production documents and labels, to meet production schedule.
• Review batch-related documentation, test methods and EM data and disposition final product.
• Ensure products are manufactured in compliance with regulatory and GMP guidelines.
• Perform lot closure and disposition activities.
• Oversee the packaging and shipping process and perform final product shipment authorization.
• Support deviation system and ensure proper investigation and root cause analysis are performed and corrective actions implemented.
• Support the CAPA system and ensure timely closure and effectiveness of investigations and corrective and preventive actions.
• Conduct effective root cause analysis and implement corrective action and preventative action.
• Support quality assessments of internal operations to analyze compliance and assess risk.
• Review and approve proposed changes to systems, procedures, and methods.
• Review and approve deviations, LIRs, OOS, in compliance with SOPs and timelines.
• Support audits.
• Support New Hire Orientation and Train-the-Trainer training content and delivery.
• Support tracking of site quality metrics to management.
• Generate, revise and/or approve standard operating procedures and associated documents as needed.
• Identify compliance risks and escalate the issues to appropriate levels of management for resolution.
• Able to support occasional off shift and weekend hours.

Requirements

• Master's Degree or Bachelor of Science degree with a minimum of 2 years of combined technical experience in a GMP related field within a biotechnology, biologics, or pharmaceutical manufacturing facility.
• Minimum of 1 year of working within Quality Systems.
• Strong knowledge of GMPs and Data Integrity Principles.

Nice-to-haves

• Knowledge of training processes/systems and regulatory requirements for US and EU (21 CFR Parts 11/210/211 and EU GMP Annex 1).
• Knowledge of Material and Batch Disposition, Operational QA activities, Deviation, CAPA, CC, Auditing practices/strategies.
• Experience in Raw Material Release/Retains and/or Review of Analytical testing records.
• Knowledge of aseptic cleanroom behaviors and cell therapy manufacturing processes.
• Gowning experience for cleanroom environment.
• Knowledge of Cell and Gene Therapies (CAR-T).
• Experience in electronic ERP, Quality Management Systems, Document Management Systems, and Training Management Systems.
• Advanced Skills with MS Office applications Word, Excel, Access, PowerPoint as well as Adobe Acrobat.
• Ability to communicate and work independently with scientific/technical personnel.
• Excellent writing and editing skills.
• Excellent interpersonal, verbal, and written communication skills are essential in this collaborative work environment.
• Self-motivated, detail-oriented, and comfortable in a fast-paced small company environment with minimal direction and able to adjust workload based upon changing priorities.

Benefits

• Medical, Dental and Vision Insurance
• Life, AD&D, Critical Illness Insurance
• Pre-tax HSA & FSA, DCRA Spending Accounts
• Employee Assistance & Concierge Program (EAP) available 24/7
• Parental and Childbirth Leave & Family Planning Assistance
• Sitterstream: Virtual Tutoring & Childcare Membership
• Paid Time Off: Vacation, Sick, Bereavement, Holidays (including Floating) & Year-End U.S. Shutdown.
• 401(K) Plan with Company Match
• Tuition Reimbursement & Student Loan Assistance Programs
• Wellbeing Incentive Platforms & Incentives
• Professional Development Programs
• Commuting Allowance and subsidized parking
• Discounted Home, Auto & Pet Insurance