Senior Specialist QA OTF Support

Senior Specialist QA OTF

About Site:
Our FDA-licensed, state-of-the-art CGMP manufacturing facility for Gene Therapies is located on the Harmans/BWI campus. The campus, featuring two manufacturing facilities is located 5 miles from the Baltimore Washington International (BWI) airport and 13 miles from our Baltimore location. The campus is close to Washington, DC’s I-270 Technology Corridor, top universities, and government agencies. The Harmans/BWI-1 EMA and FDA approved facility, at approximately 200,000 sq.

ft., houses 10 CGMP manufacturing suites, fill/finish, central services, testing labs, and a warehouse. The Harmans/BWI-2 facility, at approximately 145,000 sq. ft., is under development and will house 8 CGMP manufacturing suites and cold storage warehousing. Both facilities support Phase 3 through commercial manufacturing of advanced therapeutic products including AAV and other viral vector-based therapies and vaccines.

We have an opportunity for a Senior Specialist QA OTF Support to join our team. This role provides Quality Assurance support for GMP manufacturing of master and working cell banks, biological bulk drug substance, and finished drug product for human use. You will ensure compliance by observing manufacturing operations and reviewing documentation on the floor. The position focuses on maintaining quality standards, supporting continuous improvement, and ensuring adherence to regulatory requirements for biological products.

Shift: Monday – Friday, 8am-5pm

Location:

Harmans, MD - BWI 100% Onsite

• Provide dedicated QA quality floor oversight of GMP operations for manufacturing of cell banks, bulk drug substance, and final drug product, spending 75% of the day on the floor
• Perform QA on-the-floor activities including room release, observing critical processes, reviewing batch documentation in real time, and resolving issues during manufacturing
• Partner with Manufacturing and other support teams
• Perform Acceptable Quality Limit (AQL) visual inspection of drug product
• Review and approve batch documents for media and buffer preparation solutions
• Generate or revise GMP documentation such as Standard Operating Procedures, Master Batch Record review, and SMPs
• Compile deviations observed on the floor and ensure timely completion
• Perform audits of manufacturing and support areas, including in-process batch record review for adherence to internal procedures and Good Documentation Practices
• Make quality decisions with limited oversight
• Identify and implement continuous improvement initiatives
• Participate in site and corporate quality and process improvement initiatives
• Guide personnel involved in GMP operations on compliance, internal procedures, regulatory requirements, and industry best practices
• Actively participate in training activities and manage individual training plan
• Other duties as assigned

• Master’s degree in a Scientific, Engineering, or Biotech field with 2–4 years of experience in Quality Assurance, Quality Control, or Manufacturing within biologics, biopharmaceuticals, or a regulated industry, OR Bachelor’s degree in a Scientific, Engineering, or Biotech field with 4–6 years of experience in Quality Assurance, Quality Control, or Manufacturing within biologics, biopharmaceuticals, or a regulated industry
• Familiarity with Good Manufacturing Practices (GMPs), 21 CFR Parts 210 and 211, biological regulations per 21 CFR Parts 600s, ICH Guidelines, and EU GMPs
• Knowledge and/or exposure to biological manufacturing processes including microbial and cell culture cell banking, fermentation/cell culture, purification, and fill/finish
• Ability to apply basic scientific and regulatory principles to solve operational and routine quality tasks
• Familiarity with electronic systems and ability to develop and produce reports using Microsoft products
• Creative individual with strong analytical, troubleshooting, and decision-making skills
• Ability to quickly learn new manufacturing processes supporting new clients
• Able to work in a team setting and independently under supervision
• Ability to deliver results in a fast-paced environment to meet client deadlines