QA Specialist II, Quality Operations (Combination Products)

Unither Pharmaceuticals•RTP, NC, NC

8d•Onsite

About The Position

The QA Specialist II, 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 campus. This role involves reviewing GMP documentation, performing quality assurance functions, reviewing and dispositioning batch records, processing rejected lots, managing retention samples, handling labeling activities, creating/revising SOPs, initiating and closing quality events and CAPAs, providing data for annual quality reviews, and communicating with internal and external partners. The position also supports process initiatives for quality projects and requires the ability to escalate complex issues to management.

Requirements

Bachelor’s Degree in a scientific or related technical discipline
2+ years of relevant pharmaceutical industry experience in a cGMP regulated environment
Ability to work independently and as 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
Ability to effectively communicate with internal customers at various levels in the organization; written and oral
Ability to handle confidential company data, projects, information, etc.
Ability to interpret data in relation to a vast number of company procedures as well as current GMP requirements
Experience in review of batch records, production records, process control records
Proficient in Microsoft Excel, Word, and Adobe Acrobat

Nice To Haves

2+ years of experience in combination products
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 activities
Perform the review and disposition of manufacturing, packaging and Combination Products batch records and components for clinical and commercial processes
Review of quality control final product data
Process rejected lots of raw materials, components and Combination products identified for destruction
Process retention samples and Combination products identified for storage
Perform labeling activities, including incoming inspection, issuance, cycle counts, SAP transactions and reconciliation of labeled and printed components
Create and revise standard operating procedures (SOPs) and work instructions
Initiate and participate in the closure of quality events and CAPAs 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)
Communicate and work closely with internal and external partners to resolve quality issues.
Escalate complex issues to Quality Management.
Support process initiatives for quality projects, such as project plans, timelines and deliverables, etc.