Under the supervision of the Quality Assurance Supervisor, this person is responsible for undertaking activities to perform field QA activities: In process checks, QA approval for Area clearance for labelling, packing, AQL inspection for finished products, QC lab sampling for finished products, Retention sampling for finished products, Batch record review, final product release, review and approve various operation documents, forms. Approval or rejection for Raw materials and Final product labels. Ensure compliance of the company’s procedures for In-process activities with the Good Manufacturing Practices (GMPs). Qualified candidate must possess a strong background in Quality Assurance, Quality Compliance and Quality Systems. The qualified candidate must have experience interacting with the FDA and other regulatory/audit groups. This position will be responsible for identifying any deviations or non-conformances, writing/ revising standard operating procedures, forms, protocols, and change controls, and providing guidance to junior staff.
Responsibilities
- Regular and predictable onsite attendance and punctuality.
- Perform AQL inspection for Finished products
- Create a process flow for QC lab samples to be delivered to the QC lab from production
- Create process flow and perform Raw material and final product inspection and release.
- Review executed batch records to ensure compliance with approved procedures and communicate and resolve discrepancies with manufacturing operators or supervisors.
- Conduct Quality on the Floor activities including quality walk-throughs of the production, testing and warehouse locations.
- Provide Quality support to Manufacturing personnel on the floor; provide guidance during GMP events and initiation of deviation investigations.
- Review and approval of incoming raw materials, routine preventive, and calibration of equipment.
- Lead small scope projects as assigned.
- Train and mentor junior team members.
- Identify and facilitate continuous improvement project
- Prepare and/or revise SOPs to ensure compliance with regulations and current practices. Keep current on regulations and industry best practices and update SOPs to improve compliance.
- Prepare all necessary reports in a timely manner to meet compliance requirements and business needs.
- Interact with FDA and other regulatory/audit groups. Working knowledge of FDA regulations and application of GMPs.
Qualifications
- Minimum of Associates degree and/or equivalent combination of education and experience is required.
- Bachelor's degree in relevant science or engineering discipline is preferred.
- 4+ years of relevant cGMP experience. Experience in FDA/EMA regulations in biopharmaceuticals or sterile injectable manufacturing is preferred.
- Experience with use of complex research techniques and methodologies like six sigma and Kaizen to improve process/product quality is a plus
- 4+ years Hands-on experience with batch record review and product disposition is preferred.
- Excellent organizational and project management skills and ability to handle multiple projects
- Excellent writing and computer skills and ability to present data in a logical manner
- Excellent interpersonal and communication skills
- Must exercise accurate judgment and be able to evaluate information critically and decide upon appropriate course of action.
- Good organization and time management skills.
- Ability to work in a high paced team environment.
- Strong written and verbal skills. Demonstrated effectiveness in task completion, decision making, and problem solving.
- Working knowledge of FDA regulations, applications of GMPs. Experience interacting with personnel from regulatory agencies.
