Senior Quality Assurance Specialist

Sheffield Pharmaceuticals•New London, CT

46d

About The Position

The Senior Quality Assurance (QA) Specialist is responsible for overseeing quality systems, ensuring compliance with internal standards and external regulations, and driving continuous improvement initiatives. This role plays a critical part in maintaining the integrity, reliability, and safety of products or services through leadership in quality practices, data analysis, and cross-functional collaboration.

Requirements

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.
Working knowledge of good documentation practices and cGMP Regulations 21 CFR Part 210, 211, and 820 strongly preferred.
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.

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.