QA Associate, Weekend Day Shift

INCOG BioPharma Services; Fishers (IN); On-site; USD 55,000 - 85,000; Full time

Job summary

INCOG BioPharma Services in Fishers, IN is seeking a QA Associate to help ensure site compliance with regulations and ISO standards. The role focuses on supporting quality systems and driving a culture of efficiency and attention to detail.

You will work with the Quality Manager, perform on-floor QA activities, review documentation, and participate in deviations investigations using root cause analysis. Weekend shifts (Fri-Sun) are required with potential flexibility.

Qualifications

• Bachelor’s degree in a science field required.
• Minimum 2 years in GMP manufacturing QA.
• Knowledge of GDP, CAPA, deviations, and non-conformance.
• Excellent written and verbal communication.
• Strong computer and data analysis skills.

Responsibilities

• Maintain QA presence on the manufacturing floor.
• Review and approve QA documentation.
• Lead investigations on deviations with root cause analysis.
• Support batch record reviews and material release.
• Balance production timelines with quality assurances.
• Assist with safety and compliance initiatives.

Skills

Quality Assurance

GMP Manufacturing

Documentation

Cross-functional Collaboration

Data Analysis Tools

Communication Skills

Problem Solving

Education

Bachelor’s Degree in Science

2+ years GMP/QA experience

Tools

Veeva

SCADA

BMS

CMMS

LIMS

JMP

Minitab

Excel

Word

Visio

Job description

Working closely with the Quality Manager, the QA Associate will be instrumental in ensuring site compliance with Regulations, ISO Standards, organizations SOPs as well as support in championing and developing organization’s Quality Mindset, as well as a culture of efficiency, attention to detail, and on time delivery. The QA Associate will need to provide support with identifying operational and quality gaps.

​The QA Associate will exemplify excellent interpersonal skills and be capable of developing productive, customer‑centric working relationships with colleagues, internal customers, and partners. 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.

This role supports Weekend operations (Friday–Sunday). Two shifts are available: Days (7:00 AM–7:30 PM) and Nights (7:00 PM–7:30 AM). Candidates must demonstrate availability and flexibility for occasional support outside of their standard shift hours.

Essential Job Functions

• 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 escalation 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.

Special Job Requirements

• 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.).

Additional Preferences

• Hands‑on experience with aseptic manufacturing, inspecting finished products, and Acceptable Quality Limits (AQLs).
• Experience with Continuous improvement, Six Sigma, and/or Lean principles.

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.

Qualified applicants must be authorized to work in the United States on a full‑time basis. INCOG will not provide support for or sponsor work authorization or visas for this role, including but not limited to F-1 CPT, F-1 OPT, F-1 STEM OPT, J-1, H-1B, TN, O-1, E-3, H-1B1, or L-1.

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