Quality System Scientific Specialist Tier III

Description

Job Purpose:

The purpose of the Quality Systems Scientific Specialist (Tier III) is to responsible for ensuring data integrity, compliance, and adherence to established quality standards. This role involves analyzing reports, and identifying discrepancies or inconsistencies, and escalating issues accordingly. Contribute to continuous improvement of processes and products by identifying trends all while adhering to regulatory standards and company policies.

Essential Duties and Responsibilities:

• Responsible for ensuring compliance with all State and Federal regulatory bodies as it pertains to the completion of Annual Product Reviews (APR) for all Nephron Pharmaceuticals Corporation (Nephron) and Nephron 503B Outsourcing Facility (503B) drug products.
• Responsible for performing Quality Assurance reviews of Microbiology and Chemistry documents for final Quality Approval. This includes review of method validation protocols and summary reports, Media Fills, environmental monitoring performances qualifications, drug supply chain security act, and other related documentation provided to the Quality Systems Scientific Team.
• Review and approval of protocols and summary reports for Process Development (PD) studies, stability studies, validation studies, and additional documentation as requested.
• Review and approve initiations and final reports of laboratory investigations for Chemistry and/ or Microbiology related events.
• Stay abreast of current FDA requirements and ensure compliance by familiarity with important department Standard Operating Procedures (SOPs) and routine observance of procedures being performed.
• Report any quality related issues to Quality Systems Scientific Manager or Quality Systems Director.
• Assist in other activities (as needed) for Quality Assurance Management.

Supplemental Functions:

• Copying, filing, and scanning of documents.
• Performs other similar duties as required.

Requirements

Job Specifications and Qualifications:

• Bachelor's degree preferred with 1-2 years of pharmaceutical experience in Quality Systems or relevant area preferred.
• 1-3 years of experience with MS Word, Excel, and PowerPoint preferred.
• 1-2 years project management and coordinator experience preferred.

Knowledge & Skills:

• Written and Oral communication skills.
• Pharmaceutical experience with equipment, instrumentation, production, maintenance, and engineering preferred.
• Experience in Root Cause Analysis and technical writing skills required.
• Team Player, must be able to interact within the company with all departments.
• Experience in Root Cause Analysis and technical writing skills required.
• Specific expertise, skills and knowledge within quality assurance gained through education and experience.
• A board perspective that aligns decisions to organizational objectives and long-term consequences of day-to-day activities.
• The ability to take strategic objectives and accept accountability to drive results through effective actions.
• The ability and willingness to change direction and focus to meet shifting organizational and business demands.
• The ability to set clear targets and use performance measures to assess risk and opportunities in order to effectively manage the assets of the business. The ability to create and contribute that values people, encourages trust, teamwork, and open communication, and provides participation, learning, feedback and recognition.
• The ability to effectively manage one self, demonstrates integrity, be productive under pressure, and achieve development goals.
• The ability to take strategic objectives and accept accountability, motivate and influence others, thinks globally, and leverages diversity.
• The ability to manage a multitude of resources and to be accurate and current with data and information.
• Position requires lifting (up to 40lbs), vision (20/20), standing (10%), sitting (40%), walking (50%), talking, typing and hearing.
• Salary range: Based on experience
• Hours of work: Monday thru Friday on an 8-hour shift, or as needed based on company demand.

Education/Experience:

• Bachelor's degree in a scientific discipline or 1-2 years of related experience in the pharmaceutical industry, preferred.
• 1-3 years of experience with MS Word, Excel, and PowerPoint preferred.
• 1-2 years project management and coordinator experience preferred.

Working Conditions / Physical Requirements:

• This position requires bending, typing, lifting (up to 40 lbs.), standing, sitting and walking throughout the facility.