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Sheffield Pharmaceuticals, LLC · 2 days ago

Senior Quality Assurance Specialist

170 Broad Street, New London, CT 06320, USA

Full-time

Onsite

Senior Level

5+ years exp

Sheffield Pharmaceuticals, LLC is a company focused on maintaining high standards in quality assurance. The Senior Quality Assurance Specialist is responsible for overseeing quality systems, ensuring compliance with regulations, and driving continuous improvement initiatives within the organization.

BiotechnologyHealth CarePharmaceutical

Responsibilities

Performs daily reviews of batch records and associated data for product release and determines if records are within range of internal and cGMP regulations

Independently investigates, trouble shoots, and rectifies issues as a result of QA analysis though deviation investigations using root cause analysis tools

Participate in Customer Complaint, Corrective and Preventative Action, and Out of Specification investigations and associated actions

Perform internal audits. This includes documentation of audit findings, corrective actions, and follow-up on corrective actions

Provides QA oversight and performs real time, on-the-floor documentation review and inspections during manufacturing operations

Assists with Customer and Regulatory Audits and Inspections as a representative of the company

Support Company Quality Training Programs and new employee orientation trainings

Train, mentor, and guide junior QA staff on quality procedures, processes, and best practices

Represents Quality Assurance at meetings as requested and act as a key contact for quality concerns

Responsible for following all safety regulations and complying with SOPs, DEP, EPA, OSHA, FDA, and cGMPs while performing duties

Other assigned tasks as necessary assigned by Management

Qualification

Quality Assurance experienceProcess auditingTechnical writingCGMP knowledgeAttention to detailOrganizational skillsCommunication skillsLeadership skillsInterpersonal skills

Required

Bachelor's degree in Life Sciences or related field

5 – 8+ years of Quality Assurance experience, including at least 2 years in a lead role

Technical writing experience

Process auditing experience in a manufacturing environment including experience working with SOPs, cGMPs, and regulatory agencies such as DEP, EPA, OSHA, the FDA

Strong attention to detail and organizational skills with the ability to work cross-functionally in a fast-paced environment

Ability to communicate technical requirements and compliance expectations clearly and accurately

Excellent communication, leadership, and interpersonal skills