About the Role
The Quality Assurance Administrator will oversee and assure compliance with current good manufacturing practices (cGMP) activities, collaborating with internal and cross-departmental teams to ensure product specifications, processes, and procedures meet the highest quality and compliance standards.
Responsibilities
- Maintain, organize, and control electronic and paper quality documentation, including batch records, SOPs, inspection reports, and audit records.
- Review batch records and supporting documentation for accuracy, completeness, and compliance before product release.
- Coordinate the documentation, investigation, and tracking of quality deviations, nonconformances, and CAPAs.
- Enter and maintain quality data in tracking systems, monitor KPIs, and prepare reports on trends and improvement opportunities.
- Collaborate with Production, Quality Control, and cross-functional teams to resolve quality issues and support compliance.
- Assist with planning, coordinating, and documenting internal and external quality audits, including follow-up on findings.
- Provide administrative support to the QA department, including preparing agendas and minutes, managing documentation, and maintaining action item logs.
- Support employee training initiatives by maintaining training records and coordinating quality-related training programs.
- Ensure QA documentation and records are accurate, complete, and maintained in compliance with regulatory requirements, company policies, and quality standards.
- Maintain regular and reliable attendance on a full-time basis.
- Embody Sheffield's cultural values and align daily actions with department goals and company culture.
Requirements
- Working knowledge of good documentation practices and cGMP Regulations 21 CFR Part 210, 211, and 820 strongly preferred.
- Excellent attention to detail and communication skills required.
- Ability to prioritize tasks in a fast-paced environment.
- Proficient in Word, Excel, and PowerPoint.
Skills
- Attention to detail
- Communication skills
- Prioritization
- Microsoft Word
- Microsoft Excel
- Microsoft PowerPoint
Location
- Sheffield
Work Type
- Full-time
Education Level
- Bachelor's degree in Food Science, Quality Assurance, Business Administration, or related field preferred.
- Bachelor's degree in a Life Science or equivalent experience preferred.
- Minimum High School Diploma required.
About the Company
- Sheffield Pharmaceuticals is an OTC, drug, and medical device manufacturing company regulated by the FDA, producing creams, ointments, nasal products, and toothpastes.
- Our mission is to improve the health and wellness of humankind.
- We believe our people are our greatest assets and are committed to providing an environment that supports personal and professional growth.
Equal Opportunity
- Sheffield Pharmaceuticals is an Equal Employment Opportunity employer.
- We provide equal opportunity to employees and applicants for employment without regard to race, creed, color, religion, sex, age, national origin, physical or mental disability, sexual orientation, marital or familial status, genetic information, protected veteran status, or other basis protected by law.
