Quality Assurance Analyst Jobs in Iowa

Location: Clive, IA
Department: Quality Assurance
Reports To: Quality Assurance Manager

Position Summary

We are seeking a detail-oriented Quality Assurance Associate with 2-3 years of experience in a pharmaceutical, OTC drug, medical device, or regulated manufacturing environment. The QA Associate will play a critical role in maintaining compliance with FDA regulations, current Good Manufacturing Practices (cGMP), and internal quality systems.

This position is responsible for managing change controls, maintaining SOP and quality system documentation, reviewing batch production records, overseeing the stability program, conducting employee training activities, and generating reports to support quality and regulatory compliance. The ideal candidate is highly organized, analytical, and capable of managing multiple quality system activities while maintaining an audit-ready environment.

Essential Duties and Responsibilities

Quality Systems & Change Control

· Manage the Change Control Program from initiation through approval, implementation, effectiveness verification, and closure.

· Evaluate proposed changes for quality, GMP, validation, regulatory, and operational impact.

· Support deviation investigations, root cause analyses, risk assessments, and CAPA activities.

Documentation & Document Control

· Draft, revise, review, route, and maintain Standard Operating Procedures (SOPs), forms, specifications, and quality system documents.

· Maintain controlled documents and quality records in an audit-ready state.

· Track periodic document reviews and ensure timely updates.

Batch Record Review

· Review manufacturing batch records, packaging records, and associated documentation for completeness, accuracy, and compliance.

· Identify documentation errors, discrepancies, and GMP issues and ensure appropriate resolution prior to product release.

Stability Program Management

· Coordinate and maintain the company's stability program for OTC drug products to support initial 24-month shelf-life and further extension based on accelerated/real-time data.

· Schedule stability pulls and ensure samples are collected, stored, tested, and documented according to approved protocols.

· Maintain stability databases, logs, and testing schedules.

· Review stability data and prepare trend analyses and summary reports.

Training Responsibilities

· Coordinate Good Manufacturing Practice (GMP) training and quality system training programs.

· Maintain employee training records and training matrices.

· Assist in developing and delivering training materials related to SOPs, quality systems, and regulatory requirements.

· Ensure new and revised procedures are communicated and training is completed and documented.

Reporting and Compliance Activities

· Prepare quality system reports, metrics, trend analyses, and management review summaries.

· Generate reports related to change controls, CAPAs, deviations, training compliance, and stability activities.

· Assist with preparation for regulatory inspections, customer audits, and internal audits.

· Participate in continuous improvement initiatives designed to strengthen quality systems and operational effectiveness.

Qualifications

Education

· Bachelor's degree in Chemistry, Biology, Pharmaceutical Sciences, Quality Management, or a related scientific discipline preferred.

· Equivalent combination of education and relevant experience may be considered.

Experience

· 2-3 years of Quality Assurance experience in a pharmaceutical, OTC drug, nutraceutical, medical device, or other regulated manufacturing environment.

· Experience managing change controls, document control systems, and batch record review.

· Experience with GMP training programs and quality documentation.

· Familiarity with FDA regulations and current Good Manufacturing Practices (cGMP).

Knowledge, Skills, and Abilities

· Strong knowledge of FDA regulations, 21 CFR requirements, and cGMP principles.

· Understanding of quality systems including Change Control, CAPA, Deviations, Document Control, Training, and Stability Programs.

· Excellent technical writing and report-writing skills.

· Strong organizational skills with the ability to prioritize multiple projects and deadlines.

· Proficiency with Microsoft Office applications, particularly Excel, Word, and Outlook.

· Experience with electronic Quality Management Systems (eQMS) preferred.

· Strong analytical and problem-solving abilities.

· Excellent verbal and written communication skills.

· High level of accuracy, attention to detail, and commitment to data integrity.

Preferred Qualifications

· Experience in an OTC pharmaceutical manufacturing environment.

· Experience supporting FDA, customer, and third-party audits.

· Knowledge of risk management methodologies and quality metrics.

· Experience with stability trending and statistical analysis.

Physical Requirements

· Ability to sit, stand, and walk for extended periods.

· Ability to periodically enter manufacturing, laboratory, and warehouse environments.

· Ability to review detailed documentation and electronic records for extended periods.

Benefits

· Competitive salary

· Medical, dental, and vision insurance

· SIMPLE IRA with company contribution

· Paid time off and company holidays

· Professional development and training opportunities

Why Join Us?

Join a growing OTC pharmaceutical manufacturer committed to quality, compliance, and continuous improvement. This role offers an excellent opportunity to expand your expertise in quality systems while contributing directly to the safety, quality, and regulatory compliance of products used by consumers every day.

Pay: From $55,000.00 per year

Benefits:

• 401(k)
• Dental insurance
• Flexible schedule
• Health insurance

Work Location: In person