Quality Compliance Specialist is responsible for supporting the management of the vendor qualification program, conducting internal and external audits, compile and author annual product reviews, collecting metrics across the company, ensuring compliance to internal policies and local/federal regulations, and preparing for monthly quality council/ management review meetings.
Essential Duties and Responsibilities
- Provide oversight of the development and maintenance of the quality system, and policies
- Collects, compile and reviews metrics across the company for trending of quality performance
- Authors and reviews Annual Product reviews
- Assists in performance of internal audits and generation of audit reports.
- Supports management of the vendor/supplier qualification program including audits
- Provide support during FDA and other regulatory inspections
- Review of regulatory or other state/federal regulations regularly to maintain compliance
- Write and/or revise Standard Operating Procedures (SOP) when required
- Compiling and submitting DEA 222 forms, ARCOS and other required reports.
- Other tasks as requested
Supports other departments as directed which may include:
- Assigns and communicates corrective and preventive actions (CAPA) to responsible departments based on root cause analysis
- Assist management with organization of training program
Knowledge and Skills
- Excellent ability to organize and multi task
- Bachelors’ Degree in a life science such as Chemistry, biology or related scientific field.
- Minimum 2 years’ related experience in the pharmaceutical industry cGMP (FDA, EU, etc.) or suitable ISO certification experience (ISO13485, ISO15378, etc.)
- Understanding of 21 CFR 210/211 (cGMP) and/or Eudralex Volume 4
- Highly proficient in the use Microsoft Office applications (Word, Excel, PowerPoint).
- Maintain a safe working environment for all employees, ensuring compliance to all local, state and federal codes and regulations
- Superior communication skills (written and verbal).
- Experience with FDA, DEA, EU/EMA or other federal or state regulatory bodies
- A certifications from American Society for Quality or other. Such as: CQA, CQE, CQI, CPGP, CMQ or Six Sigma Yellow, Green, Black Belt
- Computer software validation experience (GAMP 5 or equivalent)
- Training experience