Quality Assurance Specialist

GL Staffing; Town of Florida (NY); On-site; USD 70,000 - 80,000; Full time

Job summary

GL Staffing is looking for a QA Analytical professional to ensure quality assurance in a sterile pharmaceutical manufacturing environment. The role involves conducting analytical testing that meets regulatory and internal quality standards.

The successful candidate will have over 10 years of experience in injectable product analysis and strong expertise in cGMP compliance, vendor qualifications, and cleaning validations. The salary ranges from $70,000 to $80,000 per year.

Qualifications

• Minimum of 10 years of experience in injectable product analysis and quality assurance.
• Strong knowledge of product analysis, validation protocols, and cleaning validation.
• Familiarity with cGMP documentation, SOPs, and batch release procedures.

Responsibilities

• Hands-on experience with raw materials, in-process, and finished product analysis.
• Ensure compliance with cGMP, quality specifications, and documentation standards.
• Participate in CAPA investigations, deviations, and change control processes.

Skills

Analytical testing

cGMP compliance

Vendor qualifications

OOS/OOT investigations

Cleaning validations

Education

Bachelor’s degree in Chemistry, Biochemistry, Microbiology, or related life science

Job description

We are seeking a QA Analytical to support quality assurance activities in a sterile pharmaceutical manufacturing environment. This role ensures analytical testing meets regulatory and internal quality standards.

Salary: $70,000 – $80,000 per year

Responsibilities

• Hands-on experience with raw materials, in-process, and finished product analysis
• Ability to handle cleaning validations, vendor qualifications, and review of OOS/OOT investigations
• Review and approve analytical testing data, batch release, and SOPs
• Participate in CAPA investigations, deviations, and change control processes
• Support audits and inspections by internal or external regulatory agencies
• Ensure compliance with cGMP, quality specifications, and documentation standards

Requirements

• Bachelor’s degree in Chemistry, Biochemistry, Microbiology, or related life science
• Minimum 10 years of experience in injectable product analysis and quality assurance
• Strong knowledge of product analysis, validation protocols, and cleaning validation
• Experience with handling vendor qualifications and investigations
• Familiarity with cGMP documentation, SOPs, and batch release procedures