Pay Range $48-$50 per hr.
Purpose and Scope:
The Compliance Specialist will perform critical QA tasks in support of GMP and non-GMP manufacturing programs and Regulatory Submissions at AIRM. The successful candidate will foster data integrity, quality, and compliance across a broad range of Quality Assurance areas and will work closely with talented counterparts to help ensure high quality standards and value delivery for our patients.
Responsibilities and Accountabilities:
Essential Duties and Responsibilities include, but are not limited to, the following:
• Performs QA review of executed GMP analytical batch records; in-process, release, and stability data to ensure compliance with regulatory requirements, internal quality standards, internal procedures, and contribute to the overall Quality Assurance processes.
• Performs QA review of executed development studies intended for regulatory submissions, included but not limited to, draft batch records, analytical test records, and calibration records to ensure Developmental studies are conducted and data collected in compliance with approved protocols, appropriate corporate guidelines, internal procedures, domestic and global regulatory guidelines and standards.
Identifies and reports documentation errors and deviations from test / data records, protocols, Standard Operating Procedures (SOPs), or specifications in a timely manner.
• Collaborates with cross-functional stakeholders regarding quality events, ensuring quality records are clearly written and technically sound with supporting evidence.
Required Qualifications:
• BS/BA in Life Sciences, Engineering, or Chemistry, with 2-3 years of related Quality Assurance experience within GMP-regulated industry, or 1-2 years with Masters degree. In lieu of a Life Sciences degree, consideration will be given to candidates with minimum of 6+ years of industry experience in biotechnological and/or pharmaceutical quality, manufacturing, or other industry requiring high technical aptitude and attention to detail.
• Working fluency in the Microsoft Office productivity suite (including Excel and PowerPoint).
Preferred Qualifications:
• Demonstrated knowledge of cGMPs for biotechnology, cell therapy, and/or gene therapy and other international regulatory requirements.
• Ability to interpret regulatory rules, guidance, and normative industry standards to make objective, risk-based decisions, and exercise sound Quality-by-Design principles.
...Sheet Metal Estimator Responsible for preparing and/or coordinating the preparation of full estimates on large and complex projects as required by clients documents and providing complete conceptual and total bid price. Reviewing and evaluating RFQs, RFPs and Bid...
...Adaptive Golf Internship The Golf Association of Philadelphia (GAP) is looking for a skilled and personable individual for a 2025 summer internship in our Broomall office. This three-month internship (May to August) will offer students the opportunity to learn about...
...Job Title: Ab Initio Administrator Location: Reston, VA (Remote) Duration: 9 Months Contract This position is an Ab Initio Administrator and not a developer position. The Senior Ab Initio ETL Administrator is responsible for the tasks involved in administration...
...Please read before applying: ~ Must be available to work all weekends (specific shift details below)~100% on-site in San Antonio... ...and scheduling medical evaluations in a high-volume call center environment. This role requires strong communication skills, attention...
Position Type: Instructional Certified Middle/ Math Date Posted: 11/19/2025 Location: Fruit Cove Middle School Closing Date: 11/23/2025 Comments to applicant: This will be a 40% PART-TIME POSITION working 7.5 hours per day 2 days per week and is eligible for benefits &...