QA Associate

ALLTECH CONSULTING SVC INC; Winchester (KY); On-site; USD 45,000 - 70,000; Full time

Job summary

Ein etabliertes Unternehmen sucht einen QA Associate, der für die Qualitätsunterstützung bei der Herstellung von festen oralen Arzneimitteln verantwortlich ist. Diese spannende Position umfasst die Überwachung der Produktionsabläufe, die Durchführung von Tests an Produkten und die Sicherstellung der Einhaltung von cGMP-Richtlinien. Sie arbeiten eng mit verschiedenen Abteilungen zusammen, um potenzielle Abweichungen zu identifizieren und zu beheben, und fördern eine Kultur der Teamarbeit und Kommunikation. Wenn Sie eine Leidenschaft für Qualitätssicherung haben und in einem dynamischen Umfeld arbeiten möchten, ist dies die perfekte Gelegenheit für Sie.

Qualifications

• Mindestens 2 Jahre relevante Erfahrung in der GMP-Umgebung.
• Kenntnisse in Lean Six Sigma oder ASQ-Zertifizierung sind wünschenswert.

Responsibilities

• Überwachung der Produktionsabläufe gemäß cGMP und SOP.
• Durchführung von Tests an Zwischen- und Endprodukten.
• Initiierung von Abweichungsberichten und Unterstützung bei Untersuchungen.

Skills

Qualitätskontrolle

cGMP Compliance

Dokumentenprüfung

Umweltüberwachung

Datenanalyse

Education

Bachelorabschluss in einem verwandten Fach

High School Diploma

Tools

Trackwise

JD Edwards

Job description

Job Description:

Position Overview:
The QA Associate is responsible for the Quality support functions associated with the manufacturing of solid oral dosage products for a given business unit. The essential responsibilities associated with this position are oversight of the manufacturing operations (as dictated by cGMP, CFR, and Company’s SOP) through document review/approval, real time monitoring/approval of manufacturing activities and testing/approval of in-process and finished product samples.

II. Specific Tasks, Duties and Responsibilities:
• Recommend SOP and batch record changes as needed
• Review proposed SOP revisions and provide feedback to management
• Real-time audit of batch records in the production suites for completeness, documentation, calculation errors and conformance to critical process parameters
• Perform room and equipment clearances per procedure following cleaning conducted by production.
• Perform microbial swabbing of equipment and room surfaces for environmental monitoring.
• Maintain a full understanding of all Company’s SOPs and policies along with all cGMP and CFR guidance that are applicable to the manufacturing of solid oral dosage pharmaceutical products.
• Perform routine testing of in-process and finished product samples including particle size, bulk density, moisture analysis, appearance, and AQL testing real-time.
• Monitor production manufacturing areas for compliance to SOP/cGMP/batch record and safety requirements in order to identify and resolve routine errors and prevent possible deviations that affect production real-time.
• Works cross functionally to assess impact for potential deviations and assist in identifying if an investigation is required.
• Initiate deviation problem reports in Trackwise for issues discovered by QA, providing sufficient detail of the incident so that a full investigation by the responsible department can be conducted.
• Manage quality status of WIP and finished good materials on physical inventory and in inventory system (JD Edwards)
• Other assignments as needed within the scope of QA Associate training curriculum.
• Assist in investigations for deviations by supporting data gathering and root cause analysis
• Enforcement of GMP Compliance.
• Promotes team work and good communication.
• Provide training and coaching to manufacturing staff as needed
• Support site process improvements (training, efficiency projects, implementation of CAPAs)
• Supports customer complaint investigation by performing inspection of retains and complaint samplesIII. Essential Skills and Experience:
Education or Experience: (Minimum required to perform job)
• Preferred – Bachelor’s Degree in related science or technical field in combination with 2 years prior relevant work experience.
• Minimum of High School Diploma in combination with 4+ years of relevant work experience in a regulated GMP manufacturing environment.
• Additional qualifications desired are Lean Six Sigma, ASQ certification or other professional certifications.