Senior Specialist II, Technical Quality (Sterile Ops)

Resilience-posted 4 months ago
$95,000 - $132,500/Yr
Full-time • Senior
Chemical Manufacturing
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The Technical Quality Senior Specialist II plays a pivotal role in ensuring the technical and operational quality of products, driving continuous improvement in manufacturing processes, and ensuring compliance with regulatory standards. This position requires a blend of strong technical expertise, quality assurance knowledge, and leadership capabilities to effectively collaborate across departments and lead initiatives that enhance product quality and process efficiency. The Senior Specialist II has advanced technical expertise to be able to provide quality oversight of validation, investigations, and technology transfer. They may work independently or lead specialized projects in their area of expertise, providing high-level strategic insight and technical advice.

  • Provide quality oversight for complex and/or higher-level investigations, validation protocols, and technology transfer documents, ensuring adherence to established specifications, procedures, and regulatory requirements.
  • Provide quality oversight, review, and approval of complex and higher-level 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 and/or host 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.
  • 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.
  • Bachelor's degree or higher in Pharmaceutical Sciences, Chemistry, Engineering, Life Sciences, or related field.
  • Minimum of 8 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.
  • Annual cash bonus program
  • 401(k) plan with a generous company match
  • Healthcare benefits including medical, dental, and vision
  • Family building benefits
  • Life and disability insurance
  • Flexible time off
  • Paid holidays
  • Other paid leaves of absence
  • Tuition reimbursement
  • Support for caregiving needs
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