QA Specialist (MES)

We are currently looking to fill a Quality Assurance Specialist position to support the Manufacturing Execution System (MES). This position will support a cross functional team of MES Specialists by providing a QA perspective with regards to manufacturing business processes, documentation requirements, and overall design of records. We are looking for someone who can continuously provide QA input and feedback in accordance with regulations, policies and procedures.

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

• Reviewing company documentation including SOPs, SPECS, Process Transmittals, and Manufacturing Batch Records to assess MES impact

• Identifying difficulties and suggesting alternatives that are aligned with QA

• Reviewing MES change controls and test plans

• Working with Technical Trainers to develop QA training plans for MES users

• Collaborating in the creation, review, and approval of validation documents

• Reviewing and approving MES recipes, master batch records, and electronic records to meet the requirements of manufacturing and QA users

• Supporting Pre-Production Executions (Pre-PE) and delivering feedback

• Providing end-user support for MES usage and working closely with IT to troubleshoot problems associated with QA functions

• 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 associated with quality assurance initiatives

• Review and approval of documents including SOPs, work instructions and job aids.

• Execute daily operations per strategic direction in a multifaceted environment.

• Provide mentorship during on-the-floor manufacturing

• Support audits, inspections and investigations.

This role may be for you if you:

• You have previous QA operations experience, particularly with batch record review / MES design, implementation or training

• You are a strong communicator and can use effective communication while collaborating with other functions

• You are driven and self-motivated

• You seek out new ways to improve processes and make changes accordingly

• You enjoy project work in a fast paced, startup type environment

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

• Associate QA Specialist – 2+ years

• QA Specialist – 4+ years

• Senior QA Specialist – 6+ years

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

#REGNQA

$58,480.40 - $124,300.00