QA Inspector 1st Shift

Quality Seymour, Indiana


Description

JOB SUMMARY:

• Primarily responsible for inspection and sampling of purchased, finished product received for distribution at the Seymour site
• Responsible for supporting other QA warehouse functions, including but not limited to: sampling of incoming labeling, sampling of special requests under SOP G-41 Special Request Sampling and support of Retention Sample Warehouse under SOP QA-05 Reserve Samples, Profile Samples and Clinical Reserve Samples

ESSENTIAL DUTIES / RESPONSIBILITIES:

• AQL inspection of purchased, finished product and any required sampling (release, stability, retention)
• Sampling of all incoming, purchased drug labeling
• Sampling of requests submitted under SOP G-41 Special Sampling Request
• Annual Product(Quality) Review inspection of reserve samples required by CFR 211.170(b)
• Intake and storage of all reserve and profile samples submitted per SOP QA-05 and CFR 211.170
• Process reserve sample check-out/check-in as requested or required
• Maintain continuous DEA inventory of retention samples and participate in annual physical DEA inventory per CFR 1304.11
• Maintain proper housekeeping of Retention Sample Warehouse per QA-05
• Elevate quality/compliance/DEA issues to the appropriate Quality Assessor or management in a timely manner
• Elevate issues/delays with meeting schedules or due dates to management in a timely manner
• Maintain compliance with assigned training plan(s)
• Support other Quality group functions or tasks as assigned
• Build and maintain a strong working relationship with all internal operational groups

REQUIRED EDUCATION:

High School Diploma / GED

QUALIFICATIONS/EXPERIENCE:

• Experience with SAP
• At least 5 years of experience in the pharmaceutical or related industry and knowledge of cGMPs is required along with the correct skill set.
D. SPECIFIC SKILLS:
• Must possess ability to prioritize, organize, and work effectively with minimal supervision. This includes strong follow-up skills, and the ability to provide timely closure of assigned tasks.
• Strong attention to detail is critical in this role; requires review of product labeling for compliance
• Strong communication skills (both oral and written) are needed; timely elevation of compliance issues or issues impacting scheduled completion dates
• Strong computer skills are required, with proficiency in the following applications essential: SAP and MS Excel. Familiarity with other MS Office programs is a plus (Access, Word, PowerPoint).

PHYSICAL REQUIREMENTS / ENVIRONMENT:

• MODERATE – lifting of cases and totes for sampling or storage (20 – 30 lbs.); climbing stairs to access 2nd floor retention area; climbing step stool to reach elevated racks; walking between multiple areas in the warehouse, administration and laboratory areas.
• Work is performed primarily indoors in a warehouse setting. The noise level in the work environment is moderate (primarily forklift traffic). Limited travel may be required.






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