QA Specialist- Drug Product (1st shift)

We are currently looking to fill multiple Quality Assurance Specialist (Drug Product) positions. These positions will support Quality Assurance initiatives for a broad range of  

topics relative to the start-up and operations of a Drug Product facility. 

Available Work Schedules: 

• Sunday-Wednesday, 1st shift (4x10) 

• Wednesday-Saturday, 1st shift (4x10) 

 
In this role, a typical day might include the following: 

• Work on and potentially lead efforts to establish new programs including start-up of formulation, filling, inspection, assembly, and pack and label team. 

• Perform assessments of existing procedures/documents to gauge appropriateness for the inclusion of drug product operations; where current documents are not adequate, identify path forward for establishment of procedures 

• Develop, write, review, and approve SOPs, specifications, and other documents. This includes documents for operation and facility SOPs, quality training, batch documentation, etc. 

• Accountable for maintaining project timelines to support the evolving business 

• Perform On-The-Floor quality review of documents, such as: equipment logs, training records, testing results, batch records and supporting documents. 

• Review and approval of documents (electronic and paper-based) 

• Execute daily operations per management in a multifaceted environment. 

• Perform daily on-the-floor duties to ensure facilities, equipment, materials and documentation comply with SOPs and safety standards. 

• Provide mentorship during on-the-floor manufacturing 

• Support audits, inspections and investigations 

• Perform quarantine, segregation of material and line clearances 

• Contribute to the continuous improvement initiatives  

This role may be for you if you: 

• Are able to adjust schedule based on facility start up, filling, and manufacturing needs. 

• Possess the ability to multi-task/own multiple projects while ensuring each is progressing as planned against defined timelines 

• Are good at establishing relationships and working/collaborating on cross functional teams 

• Can develop performance measures and reports to be presented to management which demonstrate progress and status of projects 

• Are able to gown for an “A” classification work environment  

Gowning and Environment 

• Full cleanroom attire (Examples may include: including laundered undergarments, gown, facemask, hairnet, safety glasses, safety shoes and booties, latex gloves and the use of sanitizing agents during gowning process including IPA)