Job Description

Quality Assurance Specialist will be the Subject Matter Expert for a specific function to evaluate and approve production department generated documentation (e.g. electronic and paper batch records).

Quality Assurance Specialist Responsibilities:

• Ability to review API (active pharmaceutical ingredients) and Drug substance product to support on-time release of product.
• Ability to provide technical guidance to production operators and management.
• Includes identifying and assessing deviations in the batch records using scientific principles, thorough analysis, and compliance minded thought processes which meet cGMP requirements within established timelines.

Quality Assurance Specialist Requirements:

• Bachelor’s degree in a scientific/ technical field.
• Minimum 7 years of overall experience in the biopharmaceutical, biologics, medical device or related industry, along with knowledge and understanding of cGMP concepts, and applicable US and foreign regulations.
• A minimum of four years of direct experience in Manufacturing and/or Quality in a GMP-regulated industry or an equivalent combination of education and experience.
• Must have previous experience reviewing and approving pharmaceutical manufacturing electronic and paper batch records and understand the review and approval process.
• Previous work in Quality Assurance (e.g., release) preferred.
• Proven ability as a team player and leader.
• Excellent interpersonal skills.
• Must be able to listen and understand the opinions and perspectives of others while influencing without authority with internal and external customers/stakeholders regarding possible recommendations.
• Ability to work both independently and team environment.
• The ability to multitask and support changing priorities.
• Strong written and oral communication skills.
• Ability to assess, investigate and resolve deviations.
• Strong ability to plan and prioritize complex and conflicting objectives to meet release goals and manage multiple priorities.
• In depth knowledge of GMP.

Job Tags

Similar Jobs