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INCOG BioPharma Services · 3 weeks ago

Senior QA Specialist, 2nd shift

Fishers, IN

Full-time

Onsite

Senior Level, Lead/Staff

8+ years exp

INCOG BioPharma Services is a world-class CDMO for parenteral injectable drugs, focused on building long-term value for customers. The Senior QA Specialist will support major QA programs, champion the organization’s Quality Mindset, and ensure compliance with quality guidelines while mentoring other QA Associates.

BiopharmaBiotechnologyManufacturingPharmaceutical

Responsibilities

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

Qualification

GMP manufacturing experienceQuality Management SystemsDeviation/CAPA managementQuality processes knowledgeStatistical analysisVeevaSCADALIMSSelf-managementCommunicationInterpersonal skillsOrganizational skills

Required

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.)

Preferred

Hands-on experience with aseptic manufacturing Quality

Hands-on experience with manual visual inspection

Company

INCOG BioPharma Services

Our services include injectable drug product formulation development, analytical method development, process scale up, and formulation & filling of vials, syringes and cartridges.

Founded in 2020

Fishers, Indiana, USA

201-500 employees