Quality Assurance Specialist III - Maryland, United States - Planet Pharma

Description

Direct Hire/ Permanent

REMOTE - must be willing to travel to the lab in Maryland - east coast preferred

$75,000—$110,000 USD

MUST HAVE

• Bachelors degree highly preferred
• 4+ years min of Quality Assurance experience
• 3+ years of recent CRO experience
• 3+ years of recent IVD and or medical device experience
• Strong audits and design control experience
• CDx and GxP experience required

Essential functions of the job include but are not limited to:

• 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 including:
• Non-Conformances
• Customer Complaints
• Planned Deviations
• Change Management
• Corrective and Preventive Action (CAPA)
• Audit Programs
• Participating on the Material Review Board
• Assist in scheduling, performing, and reporting internal audits, as well as supplier audits, and related activities
• Analyze data resulting from monthly metrics and reporting tools for all aspects of quality systems, connecting data and forming conclusions regarding the compliance health of PFM, to include presentation of metric performance to management representatives and proposing durable solutions
• Respond to supplier look-back notifications. Investigate and determine disposition of material
• Monitor equipment calibration program to ensure timely and accurate completion of maintenance
• Manage the backroom during audits and inspections, review requested documentation and records, and assist in preparing subject matter experts for audit interviews
• Support departmental projects aimed operational process understanding efforts (process mapping)
• Act as a change-agent and QA lead during continuous improvement and global harmonization efforts
• Provide guidance to junior level QA specialists
• Client-facing activities as assigned by department head such as leading client visits/audits and representing QA during project kick-off meetings and customer complaints for the CDx projects
• Create and conduct site-wide training for multiple disciplines
• Support validation activities, including review and approve validation protocols, reports, and final package documentation
• Support the maintenance and review of DHF and actively participate in all Design Control activities pertaining to the CDx projects
• 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
• Work with functional groups to develop correct documentation required to document evidence for the manufacturing/processing, testing and release of products and services
• Maintain filing and storage systems for document control, training and batch records for raw and finished product
• Collaborating with Project Management to plan upcoming quality deliverables and enforce compliance accountability
• 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