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Quality Control Specialist
2 months ago
Position: Quality Control Specialist
Contract Duration: 1 Year
Work Schedule: Monday to Friday | 8:00 AM – 4:30 PM
Role Summary
The Quality Control Specialist plays a crucial role in safeguarding the safety, effectiveness, purity, and overall quality of produced goods by adhering to applicable quality standards, regulations, and established protocols. This position is integral to the Quality Assurance Inspection (QAI) Department.
Key Responsibilities
- Make informed decisions regarding packaging evaluations, rework processes, and the final assessment of incoming materials in accordance with company policies and procedures, requiring minimal supervision.
- Prioritize incoming inspections strategically to meet the needs of the manufacturing team.
- Serve as a point of contact with suppliers to address quality-related concerns.
- Provide quality guidance and support to the Packaging and Manufacturing Operations, including quality oversight, logbook reviews, and real-time issue resolution with operational staff.
- Engage in process enhancement initiatives to eliminate unnecessary inspections and sampling.
- Demonstrate proficiency in ANSI.ASQ Z1.4 sampling plans, which are utilized for inspecting incoming, in-process, and final products to ensure compliance with established acceptance criteria.
- Possess familiarity with AQL sampling, including normal, reduced, and tightened inspections, along with switching rules.
- Have a solid understanding of cGMP as it pertains to inspection activities.
- Ability to read and interpret component schematics and utilize measurement instruments such as calipers and micrometers.
- Evaluate certificates of analysis for chemicals, raw materials, and packaging components.
- Collaborate with the Purchasing Department and suppliers to resolve discrepancies in incoming inspection documentation and shipping challenges.
- Exhibit strong organizational, communication, writing, interpersonal, and teamwork skills, with a keen attention to detail.
- Experience in a collaborative team environment, promoting a team-oriented approach and effective communication.
- Adhere to safe work practices and comply with company safety policies and guidelines.
- Maintain compliance with company policies and procedures.
- Possess knowledge of medical device or pharmaceutical packaging operations.
Qualifications
- High School Diploma or higher, with 1-3 years of experience in a GMP environment.
- Familiarity with SAP ERP systems, iLearn, QualiPSO, and STARLIMS is advantageous.
- Understanding of CGMP and regulatory compliance standards.
We foster a supportive work environment and promote an excellent organizational culture.
