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Resilience · 9 hours ago

Senior Specialist, Technical Quality

West Chester, OH

Full-time

Onsite

Mid, Senior Level

$70K/yr - $115K/yr

5+ years exp

Resilience is a technology-focused biomanufacturing company that’s changing the way medicine is made. The Senior Specialist, Technical Quality, is responsible for ensuring the technical and operational excellence of products while driving continuous improvement in manufacturing processes and maintaining compliance with regulatory standards.

BiopharmaBiotechnologyHealth CareLife SciencePharmaceutical

No H1B

Responsibilities

Provide quality oversight for investigations, validation, and technology transfer, ensuring adherence to established specifications, procedures, and regulatory requirements

Provide quality oversight, review, and approval of internal validation documents including validation plans, requirement documents (URS, FS, SRA, SLIA, and ACA), protocols, data analysis, discrepancies, and final reports

Represent the Technical Quality group in project teams, audits, and inspections, as required

Provide hands-on support and act as an SME during internal, regulatory, and customer audits and inspections

Perform reviews and approvals of investigation initial impact assessments to determine the classification of deviations

Provide quality oversight, review, and approval for deviations, CAPAs, Change Controls, and various risk assessments

In conjunction with the Lead Investigator, lead major/critical investigations and resolution of product quality issues and non-conformances, ensuring timely and effective corrective actions

Drive and support the development and implementation of continuous improvement initiatives to enhance product quality and manufacturing efficiency

Ensure manufacturing operations comply with local and global regulatory standards, including but not limited to GMP, FDA, EMA, and ICH guidelines

Collaborate with MSAT, Project Management, Engineering, and other departments to ensure seamless integration of new products and technologies into the manufacturing process

Assist in the review and approval of new product introductions, ensuring quality standards are met throughout the product lifecycle

Lead risk assessments (e.g. sFMEA) and implement strategies for mitigating technical and quality risks associated with manufacturing processes

Qualification

Quality oversightProcess validationTechnology transferRegulatory complianceRisk assessment toolsQuality management systemsMicrosoft OfficeLeadership skillsProblem-solving skillsInterpersonal skillsTechnical writing

Required

Strong technical experience in the qualification of equipment, utilities, facilities, technology transfer and process validation, and/or Quality oversight in these disciplines

Thorough knowledge of current industry best practices and regulatory guidance expectations regarding technology transfer and validation

Strong leadership, relationship management, and organizational planning

Experience supporting audits and regulatory inspections

Experience using risk assessment tools (e.g. Failure Modes and Effects Analysis (FMEA), Hazard Analysis and Critical Control Points (HACCP), Layers of Protection Analysis (LOPA), Preliminary Hazard Analysis (PHA), simple Lean tools, etc.)

Expertise in quality management systems

Excellent problem-solving skills and the ability to work under pressure in a fast-paced environment

Strong interpersonal skills with the ability to lead cross-functional teams and influence without direct authority

Excellent written and verbal communication skills, including technical writing for documents and reports

Ability and willingness to learn and adapt skills for various areas

Ability to travel approximately 5-10% based on project demand

Must have proficient computer skills and be experienced in Microsoft Office, including Word, Excel, PowerPoint, and Outlook

Preferred

Bachelor's degree or higher in Pharmaceutical Sciences, Chemistry, Engineering, Life Sciences, or related field

Minimum of 5 years of total combined experience in quality assurance and/or validation within a GMP regulated pharmaceutical and/or biotechnology manufacturing environment

Direct experience with GMP regulatory requirements relevant to pharmaceutical manufacturing

Proven track record in technical troubleshooting and root cause analysis

Prior cGMP aseptic fill/finish manufacturing experience

Experience within a multi-product facility

Experience with sterile manufacturing processes

Previous experience in leading or supporting regulatory inspections and audits