Base Salary: Confidential Bonus: Benefits: Other Compensation: A superb base salary and bonus structure are available; compensation is commensurate with experience and will be discussed with qualified candidates only.
Skills and Experience
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Qualifications / Skills Required
1) BS or MS in Chemistry or related science
2) Minimum 5 ? 10 years of experience in a pharmaceutical Quality Assurance Department
3) cGMP and GLP experience
4) Previous supervisory experience
5) Experience in hosting and managing FDA audits
6) Experience and familiarity in USP/NF methods
7) Experience in an FDA regulated environment
8) Worked in a laboratory setting (GLP)
9) Ability to develop technical plans and programs to ensure an efficient, safe and high quality laboratory operation
10) Ability to work independently, self-motivated and strong attention to detail
11) Ability to present facts and recommendations effectively in oral and written form
12) Strong interpersonal skills such as communication, relationship building, leadership, initiative, adaptable, positive attitude and team building
Job Description
Print Job Description
Partial Job Description 1) Manage a team of quality personnel 2) Conduct and/or evaluate internal auditing of all departments 3) Prepare, schedule and conduct audits of company suppliers to ensure conformance to regulatory standards and desired quality levels 4) Issue reports to audited suppliers and conduct follow-up as necessary 5) Prepare, host and manage all client, safety and governmental audits 6) Track and report planned and unplanned deviations and out of specification (OOS) trends 7) Conduct various routine tasks to maintain an effective QA/QC system 8) Ensure all company employees are trained on necessary policies and procedures, conduct BBP training, GMP training, Safety training and tour and chemistry general skills training. 9) Develop and maintain continual training program 10) Train evaluations, develop and maintain training metrics and train files 11) Create, revise and review the standard operating procedures for all departments, including revising table of contents and assigning of SOP numbers 12) Facilitate creation of new documents to ensure continuous/process improvement 13) Ensure company is within NFPA, OSHA, SARA and DOT regulations on a local, state and federal level when an issue arises, which includes training, labeling, MSDS, accident reports, fit testing and review of safety plans and radiation inventory reports 14) Monitor quality and safety goals over time and develop action plans to optimize and evolve both programs effectively under current governmental and client regulations 15) Initiate and manage out of specification investigations for all client inquires and complaints 16) Determine the root case of the issue and consult with the supervisors for corrective actions 17) Maintain Master Validation Plan protocols 18) Research, create, implement and/or improve validations and verifications
