QA Inspection Specialist

We are currently looking to fill a QA Inspection Specialist (Qualification) position. This position supports Quality Assurance initiatives for a broad range of topics relative to the start-up and operations of a Drug Product facility.

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

Visual Inspection Qualification Facilitator:

• Responsible for qualification preparation, including but not limited to documentation readiness, qualification/training kit readiness and scheduling for initial and annual requalification of visual inspectors and qualification kits

• Responsible for coordinating and reviewing progress of inspectors on evaluation assessments and qualification trials and conducting the evaluation of inspectors after qualification completion

• Provide formal instructions according to SOP/Protocol to a group of inspectors in a qualification setting

• Coordinate/supervise qualification room and ensures the environment for inspectors is efficient for qualification activities

• Oversee/monitor inspection methods and inspector adherence to protocol and procedures during qualification activities

• Maintains confidentiality and security of all qualification materials, logbooks, and other documentation as applicable

Facility Start Up:

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

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

• Accountable for maintaining project timelines associated with initiatives to support the evolving business

Operations:

• Perform On-The-Floor quality review of documents, such as: equipment logs, training records, testing results, batch records and supporting documents (electronic and paper based)

• Performs On-the- floor Visual Inspection Observation of Inspectors technique

• Review and approval of documents including executed Batch Records and SOPs (electronic and paper-based)

• Complete daily operations per management mentorship 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

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)

• Ability to remove jewelry, make-up and nail adornments when wearing cleanroom attire

This role may be for you if you:

• Have knowledge of cGMP manufacturing environment and familiarity with visual inspection of liquid and lyophilized products

• Are experienced using and / or developing qualification kits and qualifying operators

• Have optimally developed and implemented employee training programs

• Excel in a quality driven organization

• Have an understanding of biologics manufacturing operations

• Are organized and have an attention to detail

• Can prioritize multiple assignments and changing priorities

• Are able to learn and use computerized systems for daily performance of tasks

• Have the ability to pass a visual acuity exam according to SOP requirements and are able to gown for an “A” classification

To be considered for this role you must hold a Bachelor’s degree in a scientific subject area or related field and the following minimum amounts of relevant experience for each level:

• Specialist – 4+ years

• Senior Specialist – 6+ years

May substitute proven experience for education requirement. Level is determined based on qualifications relevant to the role.

#REGNQA