Senior QA Specialist, 2nd shift

Senior Quality Assurance Specialist Summary

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

The Senior Quality Assurance 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 Senior QA 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 Senior QA Specialist will thrive in a team environment but will also work autonomously utilizing strong self-management and organizational skills.  The Senior QA 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:

·       Review and approve documentation for Quality approval, including but not limited to: components/raw materials, batch records, change control requests, deviations and validation documents, etc.

·       Collaborate with Manufacturing/Operations team and lead or provide support with investigations to resolve equipment and process related deviations.

·       Maintain a Quality Assurance presence and provide process confirmation on the manufacturing floor.

·       Prioritize and coordinate his/her time in balancing production timelines with product quality assurance.

·       Perform electronic and physical release of raw materials, components, sterile consumables, media, etc.

·       Own and maintain the reference sample program.

·       Collaborate with Facilities Engineering and oversee the site’s pest control program.

·       Support batch record review and disposition.

·       Mentor other QA Associates on the shift.

·       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 (Veeva, SCADA, BMS, CMMS, LIMS, laboratory 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:

·       This position will support primarily second shift (3 pm to 11:30 pm) with occasional weekend support, dependent on operations’ needs.

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

·       Minimum of 8 years of experience working in a GMP manufacturing environment.

·       Minimum of 4 years experience of QA oversight for GMP manufacturing.

·       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:

·       Hands-on experience with aseptic manufacturing Quality.

·       Hands-on experience with manual visual inspection.

Additional info about INCOG BioPharma Services:

At INCOG BioPharma we have built a world-class CDMO for parenteral injectable drugs. Our culture and priorities are different by design: focused on building long-term value for our customers, we are committed to a service-c