We are seeking a Quality Assurance professional to oversee and support fill/finish activities (e.g. formulation, filing, inspection, packaging) at a new state-of-art contract development and manufacturing organization.
This Associate will help implement Quality procedures and standards throughout the stages of drug product
manufacturing, packaging, and release.
The Quality Associate will provide support with:
• QA release of raw materials/components
• QA Hold activities
• Operational line Clearances and AQL Inspection of final product
• Reference sample collection, audits, and coordination
• Review of Facilities and Engineering assets, work, and records, including NCRs
• Operational Logbook Closure Review
• Program Support for Pest Control, Defect Kits, and CMMS
• Pest Control Records Review
• Plant Automation A and B Alarm Review
• Primary floor support for QA Surveillance Program
Working closely with the QA Manager, the QA Associate will be instrumental in ensuring site compliance with Regulations, ISO Standards, and organizational SOPs. 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 Associate will at all times provide support with identifying and closing any identified Operational and Quality gaps.
The Quality Assurance Associate will exemplify excellent interpersonal skills and be capable of developing productive, customer-centric working relationships with colleagues, internal customers, and clients. The QA Associate 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 Associate will thrive in a team environment, but will also work autonomously utilizing strong self-management and organizational skills. The QA Associate will value process owners and subject matter experts and will possess a demonstrated ability in influencing positive outcomes without direct reporting authority.
Key Responsibilities:
• Review documentation for compliance and Quality approval, including but not limited to: components/raw material specification and release packets, QC test results, equipment records, equipment NCRs and work orders, facility records (pest control), change control requests, deviations, logbooks, etc.
• Perform production, laboratory, warehouse, and facilities area walkthroughs per an ongoing QA Surveillance program.
• Collaborate with Manufacturing/Operations team and lead or provide support with investigations to resolve equipment and process related deviations.
• Perform AQL Visual Inspection of products identifying and classifying defects. Perform re-qualification activities when needed.
• Obtain and maintain visual inspection certification.
• Maintain a Quality Assurance presence and provide process confirmation on the manufacturing floor.
• Prioritize and coordinate 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.
Minimum Qualifications
• Bachelor’s Degree required; degree preferred to be in a related Science (Chemistry, Biology, Biochemistry, Microbiology etc.)
• 2 years minimum experience working with aseptic processing in cleanroom and/or isolator environments required.
• 2 years experience as performer or reviewer in Quality Management Systems, DMS, Deviation/CAPA, and Change Control required.
• 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.).
Preferred Qualifications
• 2 years' experience with materials and production movements in SAP preferred.
• 2 years' experience responding to and assessing reporting and alarms from BMS, PAS, etc. preferred.
Additional info about INCOG BioPharma Services:
INCOG BioPharma is an Equal Opportunity Employer and prohibits discrimination and harassment of any kind. All employment decisions at INCOG BioPharma are based on business needs, job requirements and individual qualifications, without regard to race, color, religion or belief, sex (including pregnancy), age, physical disability, sexual orientation, family or parental status, or any other status protected by the laws or regulations in the locations where we operate. We will not tolerate discrimination or harassment based on any of these characteristics.
Unless otherwise specified, all positions are based out of our Fishers, IN offices. Please note, we are a smoke-free campus.
By submitting your resume and details, you are declaring that the information is correct and accurate.