QUALITY ASSURANCE SPECIALIST

Description

Shift: Monday - Friday / First shift

Bachelor's degree with 1-2 years of experience in GMP Pharmaceutical manufacturing environment required.

Duties and Responsibilities

• The QA Specialist Demonstrates sufficient depth of knowledge within own work area in order to perform hands-on routine QA tasks.
• This role supports Operations including batch record, investigation, and document review, and disposition activities.
• Resolve routine quality issues related to product manufacture and testing with guidance/coaching.
• Project work, as needed, will also be expected. Other essential duties and responsibilities in quality assurance include: Provide Quality Assurance expertise to colleagues On and off the Manufacturing floor as required.
• Identify continuous improvement opportunities based on metrics and drive consistency through the process to align with Client's standard processes and quality systems.
• Conduct regular Production areas walkthroughs (Area product clarences, GMP and compliance walkthroughs) Conduct On floor QA review of executed batch records and Logbooks to assure compliance with regulatory standards and regulatory filing. Assist Quality Operations Deviations and Product F

Physical/Mental Requirements

• Ability to gown into cGMP Manufacturing areas and adhere to governing gowning procedures as appropriate.
• Ability to stand for 1 hour at a time, walk long distances and bend to obtain items from lower shelving/cabinets.
• Occasional minimal lifting up to 20lbs.