Sheffield Pharmaceuticals, LLC
Quality Assurance Administrator
Sheffield Pharmaceuticals, LLC, New London, Connecticut, us, 06320
Position Summary
The Quality Assurance Administrator is responsible for supporting and maintaining the organization's quality management systems (QMS) to ensure compliance with internal policies, industry standards, and regulatory requirements. This role focuses on supporting the Quality Assurance team with documentation control, organizing production batch records, assisting in batch record review, supports audits, and coordination of quality-related activities across departments. Key Responsibilities
Support Sheffield Pharmaceuticals quality systems with documentation, archiving records, change control, or other quality system requirements. Supports Batch Record Review team by assisting with the review of Production Batch Records, compiling the records from the originating departments, drafting the cover sheets, and filing the records. Oversight of the batch record correction process with cross functional departments. Document Control activities of maintaining the Standard Operating Procedure (SOP) inventory list, review periods, revising SOPs, and oversight of the review and release of SOPs & STMs through the use of the Master Control System. Support external audits and inspections (e.g. FDA or client audits). Fulfills customer requests for Regulatory Information, client needs, or data requests. Collects data from multiple quality systems and composes data into metric reports. Drafts and maintains monthly Quality Unit Meeting Minutes. Maintains document retention policy and organization of records and files. Other assigned tasks as necessary assigned by Management. Qualifications
Education: Bachelor's degree in a Life Science or equivalent experience preferred. Minimum High School Diploma required. Experience: 2-5 years of experience in quality assurance, document control, compliance administration, or similar role. Skills: Strong organizational and administrative abilities to prioritize tasks in a fast-paced environment. Excellent attention to detail, accuracy, and communication skills required. Proficient in Microsoft Office (e.g. Word, Excel, & PowerPoint) and quality management software (e.g., MasterControl, SAP, or SharePoint). Working knowledge of good documentation practices and cGMP Regulations 21 CFR Part 210, 211, and 820 strongly preferred.
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.
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The Quality Assurance Administrator is responsible for supporting and maintaining the organization's quality management systems (QMS) to ensure compliance with internal policies, industry standards, and regulatory requirements. This role focuses on supporting the Quality Assurance team with documentation control, organizing production batch records, assisting in batch record review, supports audits, and coordination of quality-related activities across departments. Key Responsibilities
Support Sheffield Pharmaceuticals quality systems with documentation, archiving records, change control, or other quality system requirements. Supports Batch Record Review team by assisting with the review of Production Batch Records, compiling the records from the originating departments, drafting the cover sheets, and filing the records. Oversight of the batch record correction process with cross functional departments. Document Control activities of maintaining the Standard Operating Procedure (SOP) inventory list, review periods, revising SOPs, and oversight of the review and release of SOPs & STMs through the use of the Master Control System. Support external audits and inspections (e.g. FDA or client audits). Fulfills customer requests for Regulatory Information, client needs, or data requests. Collects data from multiple quality systems and composes data into metric reports. Drafts and maintains monthly Quality Unit Meeting Minutes. Maintains document retention policy and organization of records and files. Other assigned tasks as necessary assigned by Management. Qualifications
Education: Bachelor's degree in a Life Science or equivalent experience preferred. Minimum High School Diploma required. Experience: 2-5 years of experience in quality assurance, document control, compliance administration, or similar role. Skills: Strong organizational and administrative abilities to prioritize tasks in a fast-paced environment. Excellent attention to detail, accuracy, and communication skills required. Proficient in Microsoft Office (e.g. Word, Excel, & PowerPoint) and quality management software (e.g., MasterControl, SAP, or SharePoint). Working knowledge of good documentation practices and cGMP Regulations 21 CFR Part 210, 211, and 820 strongly preferred.
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.
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