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INCOG BioPharma Services · 14 hours ago

QA Associate, 2nd Shift

Fishers, Indiana

Full-time

Onsite

Entry Level

2+ years exp

INCOG BioPharma Services is a world-class CDMO for parenteral injectable drugs, committed to a service-culture mindset and technical excellence. The QA Associate will ensure site compliance with regulations and support operational quality, while collaborating with teams to resolve deviations and maintain high standards of quality assurance.

BiopharmaBiotechnologyManufacturingPharmaceutical

Responsibilities

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

Review and approve documentation for Quality approval, including but not limited to on-floor batch record review, logbooks, work orders, procedures, etc

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

Support other QA personnel with batch record reviews, material release, etc

Prioritize and coordinate his/her 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 (Veeva, 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

Qualification

Quality AssuranceGMP ManufacturingRoot Cause AnalysisData Analysis SoftwareDocumentation PracticesSelf-managementInterpersonal SkillsWritten CommunicationVerbal CommunicationOrganizational Skills

Required

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

Minimum of 2 years with experience working as Quality in a GMP Manufacturing environment, and/or as an Operator within a Pharmaceutical Manufacturing environment

Moderate knowledge of regulations and quality systems such as deviations, Non-Conformance, CAPA, etc

Understanding of Good Documentation Practices (GDPs) and its criticality

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, inspecting finished products, and Acceptable Quality Limits (AQLs)

Experience with Continuous improvement, Six Sigma, and/or Lean principles

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