QA Manufacturing Specialist

As a QA Manufacturing Specialist at GBI, your responsibilities include providing quality assurance support for manufacturing operations, conducting regular compliance walkthroughs, investigating quality issues, and ensuring that appropriate corrective actions are implemented. You'll also create and review standard operating procedures and oversee batch manufacturing operations while ensuring that all products meet GBI’s and regulatory standards.

To qualify for the QA Manufacturing Specialist position at GBI, candidates should have a minimum of 5 years’ experience in a pharmaceutical manufacturing environment along with at least 1 year of experience in cleanroom environments. Understanding quality assurance terminology, methods, and tools is essential, and candidates must demonstrate excellent communication skills and a deep knowledge of cGMP and Data Integrity requirements.

The work environment for a QA Manufacturing Specialist at GBI is dynamic and collaborative, situated in a state-of-the-art facility in Plantation, Florida. You’ll work closely with the Manufacturing Operations team on the manufacturing floor, conducting frequent inspections and evaluations, and engaging with high-quality biotechnology products in cleanroom settings.

GBI ensures compliance with regulatory requirements in manufacturing through rigorous quality assurance processes. As a QA Manufacturing Specialist, you will play a vital role in monitoring compliance through routine walkthroughs, investigating quality issues, reviewing batch records, and ensuring that all operations align with cGMP standards and regulatory guidelines.

At GBI, a QA Manufacturing Specialist utilizes several tools and systems, including an electronic environmental system and the NetSuite enterprise system. You'll be involved in reviewing and approving executed batch records, managing documentation controls, and ensuring compliance and quality excellence in manufacturing operations.

When addressing this question, detail your previous roles, the type of quality assurance measures you implemented, and the results. Highlight specific projects or experiences that demonstrate your understanding of regulatory requirements and your ability to maintain compliance in a manufacturing environment.

In responding to this question, outline your investigative process. Emphasize your problem-solving skills, your ability to take corrective actions promptly, and your commitment to maintaining quality and safety standards within the manufacturing process.

Discuss specific experiences you've had in cleanroom settings, emphasizing the protocols you followed to maintain cleanliness and order. Talk about your adherence to aseptic techniques and how these contribute to quality assurance during manufacturing.

Highlight your communication skills and how you facilitate collaboration among team members. Discuss any strategies or tools you use for effective communication, especially concerning quality issues and compliance requirements.

Mention specific resources, such as industry publications, webinars, and professional organizations, that you utilize to keep your knowledge current. Explain how you implement newly acquired knowledge into your daily work tasks to ensure compliance and quality.

Describe your process for developing and updating SOPs, emphasizing any specific standards you adhered to and how you ensure that all team members are trained on updated procedures to promote adherence and quality control.

Share a specific instance where you identified an area for improvement, the actions you took to address it, and the outcome of your initiative. Focus on measurable improvements in quality or compliance as a result of your efforts.

Clarify the importance of accurate records and documentation in maintaining compliance and traceability in manufacturing. Discuss your experience in managing documentation systems and how they contribute to quality assurance practices.

Illustrate your preparation process for audits, focusing on how you ensure that all records are up-to-date, compliance checks have been completed, and staff are informed and prepared to interact with auditors.

Discuss your organizational and prioritization skills. Emphasize your ability to assess situations, communicate effectively with team members, and make decisions that align with maintaining quality while meeting production deadlines.