Senior Specialist Q. A - I

Senior Specialist Q. A - Level I – Sterile Manufacturing

Position Description:

We are seeking a dedicated Quality Control Professional to support the quality oversight and testing of sterile pharmaceutical products. This role involves environmental monitoring, water sampling, utility monitoring, and aseptic technique within a regulated GMP setting. The ideal candidate will bring a strong attention to detail, a collaborative spirit, and prior experience in sterile manufacturing environments. This position will work within a 19-member team, balancing independent responsibilities with team-based collaboration. Primary duties include environmental monitoring, water sample collection and processing, and product/component release testing.

Key Responsibilities:

• Perform environmental monitoring in aseptic manufacturing areas
• Collect, process, and analyze water samples for routine and non-routine testing
• Conduct utility monitoring and aseptic sampling
• Support component and product release testing as needed
• Maintain GMP compliance in all documentation and activities
• Follow established protocols and regulatory requirements for sterile pharmaceutical production
• Apply gowning procedures to access classified cleanroom environments
• Collaborate with team members to meet departmental goals and ensure quality standards are met
• Demonstrate flexibility to support occasional early morning or late shifts as required

Skills & Qualifications:

Required Skills:

• Working knowledge of regulatory expectations for sterile product manufacture and testing
• Experience in quality assurance or quality control related to sterile pharmaceutical production
• Strong interpersonal, communication, negotiation, and relationship-building skills
• Experience with environmental monitoring techniques in GMP settings
• Ability to work independently and collaboratively within a team
• Attention to detail and strong organizational skills

Preferred Skills:

• Water sampling and filtration experience
• Utility monitoring and aseptic technique
• Prior gowning experience in cleanroom settings
• Experience with LAL/Endotoxin testing
• Process monitoring background
• SAP and/or GLIMS experience
• Previous experience at Pfizer or similar pharmaceutical companies

Education:

• B.S. degree in Biology, Microbiology, Pharmacy, Chemistry, Chemical Engineering, or a related field preferred
• High School Diploma acceptable with equivalent relevant industry experience
• Advanced degrees welcome