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QA Associate, Weekend Day Shift
INCOG BioPharma Services
- United States
- United States
Über
The Quality Assurance 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 primarily supports Weekend shift (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.
By submitting your resume and details, you are declaring that the information is correct and accurate.
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Sprachkenntnisse
- English
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