Apply on Employer Site

Resilience · 4 hours ago

Senior Specialist, Quality Assurance

USA - OH - West Chester

Full-time

Onsite

Mid, Senior Level

$70K/yr - $115K/yr

Resilience is a technology-focused biomanufacturing company that’s changing the way medicine is made. The Senior Specialist, Quality Assurance is responsible for all QA activities that support the execution of processes within Operations Teams, including batch release, change control, and regulatory interactions.

BiopharmaBiotechnologyHealth CareLife SciencePharmaceutical

No H1B

Responsibilities

Maintain a high level of understanding of relevant production processes and quality systems

Perform the QA review and approval of the following GMP documentation that has direct impact on the activities performed by, and facilities utilized in their corresponding areas as applicable:

Change Requests

Batch Records and associated documentation

Product and Component Release transactions in SAP

Quality Investigations (Deviations, Product Complaints)

Validation Plans, Protocols and Reports

Standard Operating Procedures

Accountable for disposition (release or rejection) of semi-finished and finished packaged product

Collaborate with and influence other Quality professionals across the organization to ensure consistent application and execution of key quality systems

Execute QA processes including batch record review, product disposition, and quality issue resolution to maintain the flow of products and documents to meet site objectives

Interface with applicable site support groups on projects (capital and non-capital) that impact the Operations/assigned area, and proactively ensure GMP compliance during the planning, execution, and closeout phases of these projects

Collaborate with and influence other Operations/assigned area members to facilitate process improvements and risk assessments; benchmark internal and external QA practices to identify innovative efficient and effective practices

Stay abreast of evolving regulatory compliance practices and recommend implementation strategies to site leaders

Collaborate in data analysis and report creation on quality metrics and key performance indicators

Strong collaboration between other areas to ensure consistent application of quality systems/processes across the site

Ability to work independently with minimal guidance from management

Influence in team and project meetings, advising project teams with respect to quality solutions and potential new approaches for consideration

Demonstrate leadership capabilities

Train and mentor junior members of the QA organization and provide QA coaching to other non-QA employees within the area supported

Strong performance history of consistently meeting or exceeding expectations

Hold other accountable for high standards and clarify what needs to be accomplished, why, and the consequences for the individual and/or the organization

Demonstrate a strong understanding of the technology area to which the individual is aligned

Act as an execution lead/process owner for one or more processes