Quality Assurance Administrator

170 Broad Street, New London, CT 06320, USA | Hourly | 20.00-23.00 per hour Commensurate with level of experience and skillset determined at time of interview. | Full Time

| Medical, Dental, Vision, Prescription, Life Insurance, Disability, 401k with match, Paid Time Off

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.

Key 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.