Position: Quality Assurance - Associate.
Location: Hicksville, New York.
Hours of Operation: 7:00 am to 3:30 pm Monday - Friday.
Salary: $52,000 - $62,400 + Health benefits.
Job Description:
As a Quality Assurance Associate, you will play a crucial role in ensuring the quality and safety of our OTC pharmaceutical products. This includes supporting QMS documentation, training records, quality record management, and supporting the Quality Assurance department with production line inspections and packaging component inspections when necessary.
Responsibilities:
- Maintain employee training records, training matrices, training acknowledgments, and competency documentation in accordance with internal procedures.
- Draft, revise, format, and maintain controlled quality documents, including SOPs, forms, training materials, work instructions, and quality records.
- Scan, upload, organize, and archive controlled documents and quality records within the electronic QMS/QPM system and maintain corresponding physical records as required.
- Assist with maintaining document tracking logs, follow-up lists, and status trackers for QA records, training activities, SOP revisions, and departmental deliverables.
- Support production line inspections, packaging component inspections, and other QA floor activities as needed.
Qualifications:
- Bachelor’s degree in a scientific discipline, technical writing, quality systems, or related field preferred.
- 1 year of experience in Quality Assurance, Quality Control, document control, or regulated industry experience preferred.
- Experience in pharmaceutical, OTC drug, medical device, or cGMP-regulated environments preferred.
- Knowledge of FDA regulations, including 21 CFR Parts 11, 210, and 211, preferred.
- Technical writing experience with SOPs, forms, work instructions, training materials, or controlled documents strongly preferred.
- Proficiency in Microsoft Office Suite and Google Workspace.
- Experience using Google Sheets for logs, trackers, training matrices, and basic notification/reminder workflows preferred.
- Strong attention to detail, organization, time management, and follow-through.
- Excellent written and verbal communication skills.
- Ability to work independently and collaboratively in a fast-paced, regulated environment.
- Reliable, professional, and able to work the required on-site schedule.
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Apothecus Pharmaceutical Corp.