Quality Assurance Specialist

Job Summary

We are hiring a Quality Assurance Specialist responsible for evaluating and approving production documentation, ensuring compliance with cGMP requirements. This role requires relevant technical education and a strong background in quality assurance within a GMP-regulated environment.

Job Description

• Responsible Subject Matter Expert for a specific function to evaluate and approve production department-generated documentation (e.g. electronic and paper batch records).
• Review API (active pharmaceutical ingredients) and Drug substance products to support the on-time release of products.
• 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 that meet cGMP requirements within established timelines.
• Reviewing electronic batch records, and interacting with QA staff and operations staff.
• Identifying errors in the batch records and interacting with productions to ensure that the corrections are completed in a timely manner to support the QA release of API and drug substance batches.
• The week also involves picking up paper batch records from operations (paper records consist of 10% of the reviews).
• Assist team members in archiving the paper records.

Skills Required

• 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

Education/Training/Certifications

• Bachelor’s degree in a scientific/ technical field.

Additional Requirements

• Worker Shift Start Time - 08:00 AM

Pay Rate/Salary

• $27.00 to $61.00 per hour based on qualifications.

"We are an Equal Opportunity Employer. Employment decisions are made without regard to race, color, religion, sex, sexual orientation, age, national origin, disability, protected veteran status, gender identity or any other factor protected by applicable federal, state, or local laws."

JOB-10043464