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Quality Operations Specialist - 2nd shift
Contract: 6 months durationwith possible conversion from contract to full time hire Shift: 12:00 – 10:30pm Mon-Th (10 hrs) plus weekend OT availability"
Location: Malvern, PA - ONSITE ONLY


The QA Associate is responsible for the quality support functions associated with the manufacturing. ASI is seeking a candidate who is dependable, a self starter andpossesses a strong attention to detail.The essential responsibilities associated with this position are oversight of the manufacturing operations (as dictated by cGMP, CFR, and SOP) through document review/approval and real time monitoring/approval of manufacturing activities.

Job Role 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 for completeness, documentation, calculation errors and conformance to critical process parameters
• Perform room and equipment clearances per procedure following cleaning conducted by production.
• Maintain a full understanding of all SOPs and policies along with all cGMP and CFR guidance that are applicable to manufacturing.
• 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.
• 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 samples



Requirements
Education/Experience:
• Bachelor’s Degree in related science or technical field preferred with 2+ years prior work experience in a regulated GMP manufacturing environment.

Knowledge/Skills Requirements:
• Safe work habits
• Basic math and computer skills
• Good communication skills
• Ability to follow written and verbal instructions
• Able to work with limited supervision for routine tasks
• Excellent documentation and handwriting skills
• Proficient reading and comprehension skills
• Sound decision-making, technical and problem-solving skills
• Good time management skills
• Expert technical writing and problem-solving skills
• Experienced with continuous improvement techniques
• Demonstrates initiative