QUALITY ASSURANCE SPECIALIST II

Thorne Research Inc•Summerville, SC

About The Position

At Thorne we make products that matter - ones that make people's lives better. Each day begins with a mission to help others discover and achieve their best health. We count on our team members to challenge and push the boundaries to make that happen. At Thorne, you’ll be joining a team of more than 750 passionate individuals committed to our cause of providing superior health solutions. POSITION SUMMARY: The Quality Assurance (QA) Specialist II is responsible and accountable for quality tasks and operations. Possesses and applies a broad knowledge of Quality principles, practices, and procedures. Supports Change Control process, Corrective and Preventive Action (CAPA) system, nonconforming material process, supplier qualification process, internal audit process and third-party audit process. Schedules, coordinates, and conducts audits of suppliers including, but not limited to, contract manufacturers and raw material suppliers. Works with the Material Review Board, Purchasing, and Suppliers to resolve product issues. Coordinates and manages relationships with outside contract manufacturers. Must be able to lead and work with cross-functional teams and track projects to completion. Requires experience in a cGMP manufacturing environment plus demonstrated familiarity with standard quality concepts, practices, and procedures.

Requirements

Minimum Bachelor’s degree with at least four years of related experience; or equivalent combination of education and experience. By training, education, and/or experience, must be able to perform the essential duties of their job.
Ability to effect change in a positive environment. Must be able to provide constructive arguments and sound justification as it pertains to technical and supplier requirements.
Initiates and completes reports in a timely manner.
Works independently with little direction or oversight, in a fast-paced environment.
Schedules projects and meets tight deadlines.
Ability to travel more than 50% of time.
Develops and delivers on assigned objectives within requested timeframes.
Possesses good interpersonal skills and engages others in a positive manner.
Possesses strong attention to detail.
Possesses strong verbal and written communication skills.
Raises issues and concerns promptly and offers pragmatic solutions for consideration.
Documents and presents work in a clear, accurate, and concise manner.

Responsibilities

Manages working relationships with all Thorne Research outside manufacturers. Coordinates with contract manufacturers to ensure adequate communication on and understanding of requirements.
Builds strong working relationships with purchasing, engineering, quality, planning, and the sales team when dealing with requirements for contract manufacturing and supply chain integrity.
Coordinates and performs auditing of suppliers. Includes onsite audits of contract manufacturers and other key suppliers.
Manages supplier qualification process ensuring procedures are executed accordingly and all suppliers are approved prior to purchasing from them.
Coordinates and resolves supplier quality issues. Includes investigation, resolution, follow-up, and corrective actions.
Coordinates and maintains supplier quality agreements.
In conjunction with procurement, maintains approved supplier listing.
Responsible for approval and disapproval of suppliers.
Initiates and completes customer complaint investigations. Communicates complaint investigation details, root cause, and CAPAs (when applicable) to appropriate parties.
Participates in Adverse Event board meetings to coordinate investigation of Adverse Events when applicable.
Oversees the stability program by reviewing stability data on normal and accelerated studies. Informs Quality Management and stakeholders of any anomalies or potential stability issues.
Becomes thoroughly knowledgeable of the applicable portions of Standard Operating Procedures (SOPs) and current Good Manufacturing Practices (cGMPs) and maintains knowledge base on an ongoing, timely basis as procedural changes occur without relying on management intervention or direction.
Proactively initiates the development of streamlined systems to effectively identify and resolve quality problems and process improvement opportunities.
Coordinates and participates in internal audits and inspections of various departments/processes including planning of audits, execution, preparation and communication of audit reports, and follow-up on audit findings.
Coordinates CAPA meetings and oversees CAPA documentation through EtQ. Provides support and leads when necessary, root cause analysis, and development of corrective and preventive actions.
Conducts raw material evaluations to provide feedback on alignment between supplier’s specification and Thorne’s specification. Identifies any quality risks and communicates to Purchasing, Medical, and Engineering as necessary.
Conducts Product Quality Reviews (PQR) for Australia products and for Thorne core products as directed.
Conducts mock recall exercise and provides a final report to Quality management.
Provides support during regulatory audits through note taking and serving as a runner to gather required documents. Writes, revises, and reviews SOPs, controlled forms and related documents as needed to ensure best practices and current operations. Reviews and approves documents through the change control process.
Demonstrates knowledge of department procedures and company policies, pays attention to detail in all aspects, and completes all paperwork accurately, neatly, and fully.
Participates on process improvement teams to provide quality input and direction. Ensures that documentation of improvements is completed and approved as needed.
Provides quality review and feedback on new products and processes as required.
Provides ongoing support to all employees on quality system requirements and problem solving.
Compiles and creates periodic reports for management.
Ensure compliance with cGMP, FDA, OSHA, and all other regulatory requirements, in accordance with company policy.
Adheres to company safety requirements.