Senior QA Specialist, Quality Operations (Combination Products)

Unither Pharmaceuticals•RTP, NC, NC

8d•Onsite

About The Position

The Senior QA Specialist, Quality Operations is responsible for quality operation activities related to clinical and commercial drug products in adherence with current Good Manufacturing Practices (cGMP) and corporate policies and procedures at the RTP facility. This role involves reviewing GMP documentation, performing quality assurance functions, reviewing and dispositioning batch records and raw materials, processing rejected lots and retention samples, creating and revising SOPs, initiating and participating in quality events, CAPAs, and change controls, providing data for annual quality reviews, conducting training, reviewing peer work, communicating KPIs, developing process initiatives, and participating in cross-functional projects. The specialist will work independently to interpret data and solve complex quality issues, escalate unresolved issues, and participate in client meetings and regulatory inspections.

Requirements

Bachelor’s Degree in a scientific or related technical discipline
5+ years of relevant pharmaceutical industry experience in a cGMP regulated environment
Ability to work independently and part of a multi-functional team, being able to manage and prioritize workloads, stressful situations, and deadlines and work extended hours to support business needs
Able to work extended hours to support business needs, as applicable
Experience in review of batch records, production records, process control records
Ability to interpret data in relation to a vast number of company procedures as well as current GMP requirements
Ability to effectively communicate (written and oral) with internal and external customers at various levels in the organization
Ability to handle confidential company data, projects, information, etc.
Proficient in Microsoft Excel, Word, and Adobe Acrobat

Nice To Haves

2+ years of experience in combination products
Ability to interpret multi compendia documentation (USP/EP/JP)
Knowledge of Enterprise Resource Planning System (ERP), TrackWise Digital, Systems Application and Products (SAP S4HANA), and MasterControl

Responsibilities

Review GMP documentation, including logbooks, pest control, waterlogs, calibration and maintenance reports, temperature monitoring, batch records, protocols, etc., as it relates to Combination products for accuracy, completeness, and compliance with UT policies and procedures
Perform quality assurance functions, including inspection of production equipment for cleanliness, gowning, area line clearances, in-process packaging checks, AQL inspections and floor audits, in support of manufacturing and packaging operations
Review and disposition manufacturing, packaging and Combination Products batch records and raw materials and components for clinical and commercial processes
Review of quality control final product and stability data
Process rejected lots of raw materials, components and Combination products identified for destruction.
Process retention samples and Combination products identified for storage
Create and revise standard operating procedures (SOPs) and work instructions
Initiate and participate in the closure of quality events, CAPAs and change controls assigned to Quality Operations to support cGMP processes, including complete investigations, action items, effectiveness checks, etc.
Provide Combination products data for annual quality reviews (AQR)
Conduct Quality Operations training for the Quality Team as it relates to cGMP Activities.
Review peer work assignments, as applicable.
Communicate key performance indicators and metrics to Quality Management related to Combination products processes
Develop process initiatives for Quality projects, such as create project plans, timelines and deliverables, etc.
Participate in site cross functional projects (software validation, test scripts, project planning, etc.) to ensure a harmonized approach across the organization
Works independently to interpret data and solve complex quality issues with minimum guidance with internal and third- party partners.
Escalate unresolved issues or concerns to Quality Management and affected area management
Participate in client meetings and projects as it relates to manufacturing, product scheduling, batch records, supply chain, etc. to support product pipelines
Support regulatory authority (FDA, MHRA, EMA, QP, etc.) inspections and internal audits, including documentation audit team, pre-audit facility inspections, etc.