Quality Assurance Documentation Specialist

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

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.