Quality Assurance Specialist

Job Title: Quality Assurance Specialist

Document Management

Redline and initiate Finished Goods Specification creation and revisions

Upload any new External Manufacturing documents in doc control system, e.g., Master Production Records, Specifications, BOMs

Route SOPs for review/approval

Initiate External Deviations & Change Control

Create records within eQMS to document external deviations and change controls

Support continuous improvement initiatives related to quality operations, including process optimization and system improvements.

Create and draft Work Instructions and Job Aids supporting the Finished Goods QA team

Collaborate with cross-functional teams (Manufacturing, Supply Chain, Regulatory) to resolve quality concerns.

Ensure adherence to Good Manufacturing Practices (GMP), Standard Operating Procedures (SOPs), and applicable regulatory requirements (e.g., FDA, ISO).

Relevant Requirements:

Bachelor’s degree in scientific discipline (e.g., Biology, Chemistry, Engineering) or equivalent combination of education and experience.

Minimum 1–3 years of experience in a quality assurance/quality operations role within a regulated manufacturing environment, preferably in finished goods.

Working knowledge of GMP, ISO standards, and regulatory requirements for finished goods manufacturing

Excellent attention to detail and strong analytical skills.

Strong written and verbal communication skills.

Proficiency with Microsoft Office Suite (Excel, Word, PowerPoint) and familiarity with quality management systems (QMS).

Ability to work independently, manage multiple priorities, and meet deadlines.

Prior experience in pharmaceutical, medical device, food, or consumer goods industries.