Quality Assurance Administrator

Sheffield Pharmaceuticals, LLC; New London (CT); On-site; USD 55,000 - 75,000; Full time

Job summary

Sheffield Pharmaceuticals is seeking a detail-oriented Quality Assurance Administrator in New London, CT to oversee cGMP compliance and to control quality documentation supporting product release. You will review batch records, track deviations and CAPAs, and collaborate with cross-functional teams to ensure ongoing quality improvements.

The role requires strong attention to detail, excellent communication, and proficiency with Word, Excel and PowerPoint.

Qualifications

• Bachelor's degree in Life Science, QA, Business Administration or related field preferred
• Strong knowledge of cGMP regulations (21 CFR Parts 210, 211, 820) preferred
• Excellent attention to detail and communication skills
• Ability to prioritize tasks in a fast-paced environment
• Proficiency in Word, Excel, and PowerPoint
• Bachelor's degree in Life Science or equivalent experience preferred; minimum High School Diploma required

Responsibilities

• Maintain and control quality documentation including batch records and SOPs
• Review batch records for accuracy before product release
• Coordinate deviations, nonconformances, CAPAs and corrective actions
• Enter quality data in tracking systems and monitor KPIs
• Collaborate with Production, Quality Control and cross-functional teams to resolve quality issues
• Assist with planning, coordination and documentation of internal and external quality audits
• Provide admin support to QA by preparing agendas and minutes, managing documentation
• Maintain training records and coordinate training activities for personnel
• Ensure QA documentation complies with regulatory requirements and company policies
• Embodies Sheffield's values and supports department goals

Skills

Attention to detail

Communication skills

Task prioritization

Cross-functional collaboration

Education

Bachelor's degree in Life Science or related field

High School Diploma

Tools

Microsoft Word

Microsoft Excel

Microsoft PowerPoint

Job description

Overview

Sheffield Pharmaceuticals is an OTC, drug, and medical device manufacturing company regulated by the FDA. Our products include a variety of creams, ointments, nasal products and toothpastes to promote wellness and first aid relief for our customers.

At Sheffield Pharmaceuticals our mission is to help improve the health and wellness of humankind. Every team member from manufacturing to quality programs to development and facility services are critical components to this effort. We believe our people are our greatest assets and are committed to providing our employees with an environment that supports personal and professional growth. We take pride in knowing our efforts are helping countless customers for years to come.

We are currently seeking a detail oriented, integral, and driven Quality Assurance Administrator who will be responsible for overseeing and assuring compliance with various current good manufacturing practices (cGMP) activities. The administrator will collaborate with internal and cross departmental team members to ensure the highest of quality and compliance to product specifications, processes, and procedures.

Responsibilities

• Maintain, organize, and control electronic and paper quality documentation, including batch records, Standard Operating Procedures (SOPs), inspection reports, audit records, and other controlled documents in accordance with document retention requirements.
• Review batch records and supporting documentation to ensure accuracy, completeness, and compliance prior to product release.
• Coordinate the documentation, investigation, and tracking of quality deviations, nonconformances, corrective actions, and preventive actions (CAPAs).
• Enter and maintain quality data in tracking systems, monitor key quality performance indicators (KPIs), and prepare reports that identify trends and opportunities for continuous improvement.
• Collaborate with Production, Quality Control, and cross-functional teams to resolve quality-related issues and support compliance initiatives.
• Assist with the planning, coordination, and documentation of internal and external quality audits, including follow-up on audit findings.
• Provide administrative support to the Quality Assurance department by preparing meeting agendas and minutes, managing documentation, maintaining action item logs, and ensuring timely follow-up.
• Support employee training initiatives by maintaining training records, coordinating training activities, and assisting with quality-related training programs for personnel across the organization.
• Ensure QA documentation and records are accurate, complete, and maintained in compliance with applicable regulatory requirements, company policies, and quality standards.
• Regular and reliable attendance on a full-time basis [or in accordance with posted schedule]
• Embodies Sheffield's cultural values and aligns daily actions with department goals and company culture.

Qualifications

• Bachelor's degree in Food Science, Quality Assurance, Business Administration, or related field preferred.
• 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
• Bachelor's degree in a Life Science or equivalent experience preferred. Minimum High School Diploma required.

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.