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Packaging Quality Control Specialist
2 months ago
At Amerisource Health Services LLC, our team members are integral to our mission of fostering healthier futures. Every individual plays a crucial role in our commitment to enhancing the well-being of both people and animals.
Your Role:
As a Packaging Quality Control Specialist, you will be working the 2nd Shift, from 3 pm to 11:30 pm. This position is vital for maintaining compliance with all regulatory standards set forth by our division, corporate guidelines, and government regulations.
Key Responsibilities:
- Ensure adherence to safety protocols and report any hazardous conditions to your supervisor promptly.
- Provide leadership and direction for daily Quality Assurance and Production operations.
- Conduct audits of production batch records throughout the packaging process to ensure accuracy and compliance.
- Perform final audits before submission for product release.
- Engage in serialization tasks, including printing, releasing, suspending, and cloning work orders to meet production demands.
- Verify and rectify discrepancies in non-controlled products and packaging components within relevant systems.
- Ensure that all deviations and necessary documentation are included in the batch record.
- Conduct Quality in-process checks as required.
- Execute Specific Gravity testing and TOC analysis.
- Carry out Cleaning Validation swabbing as requested by the Stability department.
- Create, review, and update Work Instructions (WIs) and Standard Operating Procedures (SOPs) relevant to daily tasks.
- Escalate non-conformance issues during production to management and participate in root cause analysis for quality incidents.
- Actively participate in all technical and compliance training as a member of the quality team.
Collaboration:
Work closely with supporting departments (Sampling, Label and Documentation, Production, Warehouse) to address issues and enhance processes through continuous improvement initiatives.
Internal Audits:
Participate in the site internal audit team representing Quality Assurance Production. Ensure compliance with cGMP and safety regulations while understanding SOPs.
Qualifications:
- High school diploma or equivalent experience required.
- Minimum of five years of relevant work experience in quality assurance within pharmaceutical packaging.
- Proficient in reading and understanding English for documentation and product labels.
- Strong written communication skills for accurate compliance documentation.
- In-depth knowledge of quality assurance functions and problem-solving skills for troubleshooting production issues.
- Basic mathematical skills and strong interpersonal abilities to foster cooperative working relationships.
- Excellent organizational skills with attention to detail.
- Ability to follow detailed instructions and work independently on multiple tasks.
- Proficient in ERP systems and Microsoft Office Suite (Outlook, Word, Excel).
What We Offer:
Amerisource Health Services LLC provides a comprehensive compensation package, benefits, and resources that promote an inclusive culture and support your professional growth.
