Description

Working closely with the QA Manager, the QA Senior Specialist will be instrumental in supporting major QA programs. They will also be key in championing and developing the organization's Quality Mindset, and culture of efficiency, attention to detail, and on-time delivery. The QA Senior Specialist will at all times provide support with identifying and closing Operational and Quality gaps.

The Quality Assurance Senior Specialist will exemplify excellent interpersonal skills and be capable of developing productive, customer-centric working relationships with colleagues, internal customers, and external partners and clients. The QA Senior Specialist will demonstrate excellent written and oral communication skills with the ability to clearly and concisely articulate complex issues to a range of target audiences. The QA Senior Specialist will thrive in a team environment but will also work autonomously utilizing strong self-management and organizational skills. The QA Senior Specialist will value process owners and subject matter experts and will possess a demonstrated ability in influencing positive outcomes without direct reporting authority.

Essential Job Functions:

Full lifecycle review and disposition of parenteral manufacturing Batch Records (Formulation, Filling, Inspection, & Packaging) for Media Fills and Drug Product.

Provide Client access and support in the review and approval of Batch Records

Provide training to all QA Associates and Specialists on surveillance oversight and on-the-floor Batch Record review requirements.

Support Quality Systems with driving timely completion of batch impacting deviations to support on time batch release activities.

Create and report batch release metrics to site leadership.

Participate in operations investigations for determining root cause and assessing mitigation for Major and Critical deviating events.

Support authoring, reviewing and approving of various SOPs & Work Instructions.

Support Plant Automation alarm reviews.

Advise and approve the builds of Batch Record BOMs and ECOs.

Prioritize and coordinate their time in balancing production timelines with product quality assurances.

Exercise rapid decision-making in the preliminary evaluation of the scope and impact of deviating events, requirements for product segregation, and the implementation of initial corrective actions or escalate the issue to Manager for resolution.

Provide support as needed in a cross-functional capacity on deviation investigative processes using root cause analysis tools, report writing, and mitigation development using risk analysis tools.

Exemplify and take proactive approaches in terms of safety expectations, practice positive intervention, and enforce best practices that align to SOPs, compliance requirements, quality guidelines, and site goals.

Utilize various paper and automated systems (eDMS, SCADA, BMS, CMMS, LIMS, lab instrument software, etc.) to ensure data integrity for site policies, procedures, and batch records.

Use technical skills and applied statistics to analyze and track deviations and to identify sources of variability and error site processes.

Ability to manage multiple projects in a fast-paced environment.

Special Job Requirements:

Bachelor's Degree required; degree preferred to be in a related Science (Chemistry, Biology, Biochemistry, Microbiology etc.)

7 years minimum experience working in a GMP environment.

5 years minimum experience working with aseptic processing in cleanroom and/or isolator environments required.

3 years experience of Quality Assurance oversight of aseptic manufacturing and all production stage batch record review and disposition.

3 years experience as performer or reviewer in Quality Management Systems, DMS, Deviation/CAPA, and Change Control required.

Extensive knowledge of regulations and quality processes involving product disposition.

Excellent written and verbal communication skills.

General computer skills evidenced by hands-on work with computerized Operations equipment (SCADA); and reporting and data analysis software (Word, Excel, Visio, JMP, Minitab, etc.).

Additional Preferences:

2 years' experience with assessment and review of Quality Control testing, CoA, and results management preferred.