Randstad Life Sciences US
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 at Company to help ensure high quality standards and value delivery for our patients.
Job Details
Location: Westborough, Massachusetts
Job Type: Contract
Salary: $40.00 - 44.07 per hour
Work Hours: 9 to 5
Education: Bachelors
Responsibilities
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, including 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, 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.
Qualifications
BS/BA in Life Sciences, Engineering, or Chemistry, with 2-3 years of related QA experience within GMP‑regulated industry, or 1-2 years with Master’s degree.
Working fluency in 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.
Skills
Quality Assurance, MS‑Excel, GMP (Good Manufacturing Practice), Good Manufacturing Practices (GMP), Quality Assurance (QA), Batch Record
Equal Opportunity Employer Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.
At Randstad, we welcome people of all abilities and want to ensure that our hiring and interview process meets the needs of all applicants. If you require a reasonable accommodation to make your application or interview experience a great one, please contact HRsupport@randstadusa.com.
Pay offered to a successful candidate will be based on several factors including the candidate’s education, work experience, work location, specific job duties, certifications, etc. In addition, Randstad offers a comprehensive benefits package, including: medical, prescription, dental, vision, AD&D, and life insurance offerings, short‑term disability, and a 401K plan (all benefits are based on eligibility).
This posting is open for thirty (30) days.
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Job Details
Location: Westborough, Massachusetts
Job Type: Contract
Salary: $40.00 - 44.07 per hour
Work Hours: 9 to 5
Education: Bachelors
Responsibilities
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, including 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, 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.
Qualifications
BS/BA in Life Sciences, Engineering, or Chemistry, with 2-3 years of related QA experience within GMP‑regulated industry, or 1-2 years with Master’s degree.
Working fluency in 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.
Skills
Quality Assurance, MS‑Excel, GMP (Good Manufacturing Practice), Good Manufacturing Practices (GMP), Quality Assurance (QA), Batch Record
Equal Opportunity Employer Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.
At Randstad, we welcome people of all abilities and want to ensure that our hiring and interview process meets the needs of all applicants. If you require a reasonable accommodation to make your application or interview experience a great one, please contact HRsupport@randstadusa.com.
Pay offered to a successful candidate will be based on several factors including the candidate’s education, work experience, work location, specific job duties, certifications, etc. In addition, Randstad offers a comprehensive benefits package, including: medical, prescription, dental, vision, AD&D, and life insurance offerings, short‑term disability, and a 401K plan (all benefits are based on eligibility).
This posting is open for thirty (30) days.
#J-18808-Ljbffr