Quality Specialist II

Job Description

Job Summary:

• The Specialist R&D Quality & Compliance (R&D Q&C) is responsible for the administration of integrated and comprehensive quality systems and controls that are appropriate, effective, efficient and continuously improving in order to ensure that R&D functions are operating in full compliance with sound scientific practice, Current Good Manufacturing Practices (CGMP), and within client policies and Standard Operating Procedures.
• The Specialist is responsible for participating on documentation quality review/approval of R&D Sales Samples and R&D Product Quality Complaints (PQCs).
• In addition to these tasks, supporting documentation maintenance and archival, quality inspections of R&D products, and in internal assessments on R&D processes specific to GxP.
• The Specialist must be knowledgeable to provide guidance on applicable Regulations (FDA, ICH, EU, and others) pertaining to business partners.

Duties and Responsibilities:

• Participate in GMP documentation review and approval of sales samples including identifying opportunities to optimize release processes for agility and speed to customer sales teams.
• Participate in working with various functional groups, as needed, to conduct problem identification and resolution along with assisting in compiling documentation to review and approve assessments and/or investigations for R&D Product Quality Complaints (PQC).
• Support in the development and implementation of GMP and Quality & Compliance processes and procedures including supporting GMP documentation review and approval.
• Support on internal assessments of R&D GMP processes and areas and identify opportunities to streamline.
• Support in inspection readiness activities.
• Support quality inspection of supplies for R&D studies.

Requirements:

• Experience of the overall product development process.
• Problem solver (proactive in providing and executing solutions).
• Knowledge of procedures governing R&D GMP, Analytical/Micro and GLP activities.
• Working knowledge of applicable regulatory requirements (cGMPs and cGLPs) governing various.
• Product classification types (cosmetic, OTC/OTC Monograph and Medical Devices).
• Ability to Independently plan, organize, co-ordinate, manage, and execute assigned tasks.
• Ability to work collaboratively in team environments.
• Written and oral proficiency in the English language.
• Strong communicator with excellent interpersonal skills and diplomacy.
• Good conflict handling/negotiation skills.