Quality Assessor I - Material Compliance

Job Description

Job Description

Description:

Summary

Primarily responsible for review and disposition of active pharmaceutical ingredients, excipient ingredients, primary packaging components, and drug labeling. Also responsible for final review of laboratory data (as needed). Responsible for maintaining supporting systems such as SCRAPS, Quality/Regulatory Holds, and Material Certification.

Maintain a current knowledge of pharmaceutical cGMPs, current industry trends, and Guidance Documents issued by various international regulatory bodies (e.g., FDA, EMA, etc.).

Responsibilities

• Responsible for review/disposition of executed material documentation for raw materials, primary packaging components and labeling.
• Responsible for final review of laboratory data (as needed)
• Generation of material Certificates of Analysis for use in submissions, or upon customer request.
• Assure compliance with US, EU, Japanese, and Chinese cGMPs and other regulations as required
• Verify all SAP documentation corresponds correctly to the Raw Materials, Pkg Materials and Labeling prior to disposition
• Verify no existing Quality Issues prior to disposition (could include supplier investigations, open material evaluations, Deviations, OOS etc…)
• Responsible for maintaining the Material Certification process.
• Responsible for maintaining the SCRAPSsystem.
• Responsible for maintaining the Quality/Regulatory Hold system for raw materials and packaging materials.
• Provide support in maintaining compliance with QA agreements with external customer/suppliers
• Build and maintain a strong working relationship with all internal and external operational groups.
• Responsible for working cooperatively with internal departments to address general compliance issues and provide input regarding proper documentation, handling, and quality impact.
• Support and / or assist in external and internal audits, and regulatory inspections.

Experience

Bachelor's Degree and at least 4 years of experience in the pharmaceutical or related industry with previous experience in quality/laboratory, and demonstrated use and knowledge of cGMPs is required.

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 mandatory, as the primary responsibilities of this position are technical assessment of the completion, validity and compliance of laboratory data; and the compliance of labeling to the approved label proofs.
• Strong computer skills are required, with proficiency in the following applications essential: MS Word, MS Excel, and MS Access. Familiarity with SAP, Master Control, Sample Manager, and Chromeleon are beneficial.
• Strong technical writing and problem-solving skills. Experience in reviewing scientific documents / reports to assure compliance is a plus.
• Good interpersonal skills with ability to achieve consensus and cooperation with varying departments and personalities are preferred. Strong communication skills (both oral and written) for internal and external contacts are required.

Physical Requirements

• LIGHT - Exert up to 20 lbs. of force occasionally, and / or up to 10 lbs. of force frequently, and / or a negligible amount of force constantly to move objects. Physical demands are in excess of those of sedentary work. Light work usually requires walking or standing to a significant degree.
• Work is performed primarily indoors in an office setting. The noise level in the work environment is low to moderate. Limited travel may be required.