QA Specialist - QMS

QA Specialist

• QMS GL Staffing Services, Inc.
• 3.3 Boca Raton, FL Job Details Permanent | Full-time $70,000
• $80,000 an hour 1 day ago Benefits Health insurance Dental insurance 401(k) Paid time off Vision insurance Flexible schedule Qualifications Biology Investigations regulatory compliance Laboratory document review Document control within pharmaceutical industry Production deviation management GMP Internal investigations Change management Analysis skills Bachelor's degree Pharmaceutical company experience Quality assurance within pharmaceutical industry Regulatory/legal compliance standards in production Chemistry Investigating compliance violations Standard operating procedures (SOPs) Pharmaceutical manufacturing facility experience

Full Job Description Job Title:

Quality Assurance (QA) Specialist

• QMS / Investigations (Injectables)

Location:

Boca Raton Salary:

$70,000

• $80,000 per year

Experience Required:

Minimum 10 years

Industry:

Pharmaceutical / Biotech (Injectables)

Job Summary:

We are seeking an experienced Quality Assurance (QA) Specialist with strong expertise in Quality Management Systems (QMS) and pharmaceutical manufacturing, specifically within injectables. The ideal candidate will have extensive experience handling deviations, investigations, change control, and quality documentation while ensuring compliance with regulatory standards.

Key Responsibilities:

Manage and oversee Change Control processes to ensure compliance with internal procedures and regulatory requirements. Conduct and review compliant investigations, including OOS (Out of Specification) and OOT (Out of Trend) events. Review and support quality investigations related to manufacturing and laboratory activities. Maintain and review material specifications, SOPs, and batch documentation. Perform batch record review and batch release activities. Ensure adherence to GMP regulations and company Quality Management System (QMS). Collaborate with cross-functional teams including Manufacturing, QC, and Regulatory Affairs. Support audits and regulatory inspections as needed.

Qualifications:

Minimum 10 years of Quality Assurance experience in the pharmaceutical or biotech industry. Strong experience with injectable products. Proven expertise in QMS, Change Control, Deviations, OOS/OOT investigations. Experience reviewing SOPs, material specifications, and batch release documentation. Solid knowledge of GMP regulations and regulatory compliance. Strong analytical, documentation, and problem-solving skills. Bachelor's degree in Chemistry, Biology, Pharmaceutical Sciences, or related field preferred.

Compensation & Benefits:

Salary range: $70,000

• $80,000 Competitive benefits package Opportunity to work with a growing pharmaceutical organization #Pro123

Job Types:

Full-time, Permanent Pay:

$70,000.00

• $80,000.

00 per hour

Benefits:

401(k) Dental insurance Flexible schedule Health insurance Paid time off Vision insurance

Experience:

injectables pharmaceutical industry: 3 years (Preferred) change control: 2 years (Preferred) validation: 2 years (Preferred) Ability to

Commute:

Boca Raton, FL 33486 (Required)

Work Location:

In person