Quality Assurance Specialist

Quality Assurance Specialist - Urgently hiring in Albany!

Job Title:

Quality Assurance Specialist Pay: $24.00 - $25.00/hr

Hours:

Day Shift, Monday-Friday

Start Date:

ASAP Looking for a rewarding role where your attention to detail and quality standards make a real difference? This position offers a fulfilling opportunity to uphold product quality and ensure compliance with current Good Manufacturing Practices (cGMP) in a dynamic, regulated manufacturing setting. As a Quality Assurance Specialist, you will be a key member of the Quality Unit, ensuring day-to-day compliance with cGMP, company procedures, and regulatory requirements.

You'll work closely with cross-functional teams to support quality system improvements, perform audits, and review records to keep operations running safely and smoothly.

• Supporting manufacturing operations while maintaining and developing a deep understanding of company processes and procedures.
• Conducting routine internal facility audits using structured templates and tracking findings through to closure.
• Reviewing batch production records (BPR), approving quality and manufacturing records, creating Certificates of Analysis, and dispositioning materials as assigned.
• Evaluating suppliers by reviewing questionnaires, quality agreements, and supporting vendor qualification program documentation.
• Supporting Deviations, CAPAs, Change Controls, and risk assessments (FMEA), while assisting with contamination control and environmental monitoring programs.
• Assisting with validation and qualification protocols (process validation, IQ/OQ/PQ) and summarizing results in final reports.
• Helping implement and maintain document control and training within the eQMS while contributing to continuous improvement initiatives.

• Working knowledge of cGMP and quality management systems, with experience in documentation, batch record review, internal audits, and vendor evaluation.
• Preferred 2+ years of Quality Assurance experience in a cGMP or equivalent regulated environment, including familiarity with 21 CFR 210 and 21 CFR 211.
• Meticulous attention to detail, strong technical writing skills, and excellent cross-functional collaboration.
• Self-management abilities to prioritize and complete tasks on time in a fast-paced environment.
• Ability to don required PPE, work in a cleanroom/laboratory setting, and access reliable transportation between Oral Bio Tech locations.
• Physical ability to sit or stand for extended periods, bend/stoop/reach, and lift up to 25 pounds (occasionally up to 50 pounds).

• Competitive pay of $24.00 - $25.00 per hour.
• Consistent, full-time schedule in a professional manufacturing environment.
• A meaningful role where your oversight directly impacts product safety, regulatory compliance, and high-quality standards.
• A collaborative team environment through a premier placement Opportunity with Selectemp.

This position is on-site across local facilities in Albany and offers a full-time schedule, Monday through Friday.