Position Summary:

The Quality Assurance Specialist II will provide intermediate-level, hands-on support from a regulated systems perspective in a GxP laboratory services and kitting production environment. Activities include but are not limited to, product label control, internal auditing, and quality inspection & release of raw materials, in-process materials, finished products, and critical components. In addition, this position is responsible for providing backup for the document and record control system. Extended work hours may be necessary in order to meet business demands.

Essential duties include but are not limited to:

Quality Function:

• Perform review of laboratory data for cell based and flow assays such as PK, Nab, ADA, and ELISot
• Assist in maintaining established company-wide GxP quality systems, actively managing assigned activities (including logging and tracking of events and outcomes), and working with end-users on thorough documentation of quality system events (to include closure or resolution in a timely manner):

*Non-Conformances

*Customer Complaints

*Planned Deviations

*Change Management

*Corrective and Preventive Action (CAPA)

*Supplier Quality Management

*Audit Programs

*Employee Training

*Document & Record Control

• Participating on the Material Review Board
• Assist in scheduling, performing, and reporting internal audits, as well as supplier audits, and related activities
• Maintain monthly metrics and reporting tools for all aspects of quality systems, to include presentation of metric performance to management representatives
• Respond to supplier look-back notifications. Investigate and determine disposition of material
• Monitor equipment calibration program to ensure timely and accurate completion of maintenance
• Independently conduct internal audits, supplier evaluations, and desk audits working with end users to identify performance issues and risk mitigation strategies
• Manage the backroom during audits and inspections, review requested documentation and records, and assist in preparing subject matter experts for audit interviews

Operations Support:

• Actively participate in daily operations as an on-the-floor QA representative and conduct process observations to written SOPs/accuracy of batch record/test method execution, and mentor personnel in industry best practices
• Serve as quality lead for validation activities, including review and approve validation protocols, reports, and final package documentation
• Assist in the QA review and acceptance of customer specifications to conform to contractual requirements
• Generate and maintain label formats for manufactured and resale products
• Generate and maintain Certificates of Analysis for finished products and products for resale
• Inspect and approve all product labels generated by Operations
• Provide support to other departments regarding requests, release status, regulatory requirements and other tasks as requested
• Develop and distribute controlled quality system documentation
• Work with functional groups to develop correct documentation required to document evidence for the manufacturing/processing, testing and release of products and services
• Develop and maintain databases/spreadsheets for document control
• Maintain filing and storage systems for document control, training and batch records for raw and finished product
• Perform area walkthroughs and audits for compliance to written expectations
• Collaborating with Project Management to plan upcoming quality deliverables and enforce compliance accountability

Inspection and release:

• Inspect and release incoming raw material, critical components, packaging and labeling in accordance with individual specifications and standard operating procedures
• Perform batch record review and release for finished product, raw materials, intermediate solutions, and services
• Conduct product inspections, review repack records

Miscellaneous:

• Participate actively on the safety committee, as needed
• Assist in training new and existing personnel
• Participate in regulatory, notified body, and customer audits as needed
• Provide back-up coverage for other Quality Specialists
• Carry out other duties/projects as assigned

Qualifications:

Minimum Required:

• Bachelor’s Degree or equivalent combination of education and experience
• 2 years of related experience in a life science, regulated environment

Other Required:

• Experience working in a Quality Department, including experience independently conducting internal audits, document review from a technical and quality perspective, batch release, incoming inspection knowledge of root cause analysis tools and application, identifying durable corrective/preventative actions, and participating in process improvements
• Ability to meet deadlines and perform administrative functions
• Microsoft Office suite proficiency including Office Word, Excel, PowerPoint
• Ability to organize tasks, work independently and adapt to changing priorities
• Ability to function in a minimally supervised environment with exceptional attention to detail required
• Demonstrated highly developed communication skills including well-developed writing skills and verbal and interpersonal skills
• Must be able to read, write, speak, fluently and comprehend the English language