Specialist II, Quality Assurance Operations
- Gaithersburg, Maryland
- Work experience
- Quality Management, Quality Assurance
Specialist II, Quality Assurance Operations
This position is based in Gaithersburg, MD at our newly formed clinical manufacturing site for BioNTech US. Together with the BioNTech US North American Headquarters in Cambridge, MA, both the Gaithersburg and Cambridge sites are an important part of our global effort to pioneer the development of next-generation immuno-oncology therapies that expects to experience significant growth in the near future. BioNTech US is a subsidiary of BioNTech SE with a strong foundation in Europe and a focus on the development of novel neoantigen-targeted T cell therapies, complementing BioNTech’s highly innovative scientific approach and diversified pipeline of transformative cancer medicines. As a key research and clinical development hub, BioNTech US will enable BioNTech’s growing presence in the US.
Here, you’ll achieve greatness.
- 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.
What you have to offer.
- Bachelor of Science degree with a minimum of 3 years of combined technical experience in a GMP related field within a biotechnology, biologics, or pharmaceutical manufacturing facility.
- Knowledge of training processes/systems and regulatory requirements (21 CRF Part 11/210/211).
- Minimum of 1 year of working within Quality Systems.
- Strong knowledge of GMPs.
- Knowledge of Disposition, QA Ops, Deviation, CAPA, CC, Auditing practices/strategies. Excellent writing and editing skills.
- Works on multiple assignments in collaboration with various department system owners.
- Knowledge with aseptic manufacturing processes.
- Advanced Skills with MS Office applications Word, Excel, Access, PowerPoint as well as Adobe Acrobat.
- Experience in electronic ERP, Quality Management Systems, Document Management Systems, and Training Management Systems.
- Ability to communicate and work independently with scientific/technical personnel.
- 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 for you.
- Medical, Dental and Vision Insurance
- Life, AD&D, STD and LTD Insurance
- HRA & FSA Spending Accounts
- Health & Wellness, including free onsite gym access
- Adoption & Surrogacy Assistance
- Vacation and Unlimited Sick Time
- Holidays and Floating Holidays, including discretionary winter shutdown
- 401(K) Plan with Significant Company Match
- Tuition Reimbursement and Professional Development
- Commuting Assistance and free onsite parking
- Discounted Home and Auto Insurance
- Pet Insurance
Have we kindled your pioneering spirit?
For those who require assistance due to disability, or have questions prior to applying, please email firstname.lastname@example.org.
*BioNTech does not differentiate on the basis of gender, race or ethnicity, religion, color, sexual orientation or identity, disability, age and other protected statuses as given by applicable law. We are committed to creating a diverse environment and are proud to be an equal opportunity employer. Most important – it’s a match!