Quality Professional - Pharmaceutical Manufacturing

Our dynamic work environment is looking for motivated candidates ready to thrive. Are you ready to make an impact in pharmaceutical manufacturing? Apply today!

 Tower Laboratories is a leading effervescent product manufacturer in the U.S. We develop and manufacture over-the-counter medications, prescription pharmaceuticals, nutritional supplements, soft drink tablets and other consumer products on a contract basis. We are continually expanding our effervescent product base and currently have several new and interesting products in the research and development phase right now. We are a family owned company and have been in business for over 40 years. www.towerlabs.com. 

POSITION SUMMARY:

This position will assist in the management, administration, and maintenance of the Quality System to ensure compliance with internal and external requirements and in the maintenance of regulatory/compliance documentation pertaining to materials and vendors. The individual will assist in managing Tower’s Quality programs including, but not limited to, the Deviation Management, Change Control, Corrective/Preventative Action, and Food Safety programs. This individual will interact with customers as needed to support their documentation and compliance requirements.  The individual will also partner with Quality Management and other departments to drive continuous improvement and process improvement initiatives related to product safety. 

RESPONSIBILITIES:

• Facilitates material and vendor compliance programs. This includes but is not limited to documentation reconciliation, logging, performing risk assessment and the required investigations, responding to consumers, and tracking and trending.
• Responsible for all material and vendor compliance activities including liaison with vendors and customers regarding any information they may require for registration or supplier approval.
• Review and approve vendor documentation to ensure compliance with regulations, internal standards and local regulations.
• Oversee execution of Annual Product Reviews (APRs) and conduct relevant statistical analyses.
• Lead root-cause analysis events, manage deviations, and implement corrective actions.
• Partner with the Compliance Department to investigate and resolve customer complaints.
• Assist with the execution of R&D trials, new product launches, validation activities and evaluation of new materials or alternate vendors.
• Interface with other departments and lead Continuous Improvement projects to drive Quality initiatives to ensuring product safety and process efficiency.
• Manage the facility’s Corrective and Preventative Action (CAPA) program.
• Manage the internal Change Control program and oversee execution of risk assessments.
• Learn and perform routine Quality Assurance review activities, as needed, for backup purposes.
• Assist with implementation of ERP system.
• Develop policies, procedures, SOPs, and test protocols, as needed.   
• Other responsibilities as assigned.

ESSENTIAL SKILLS and EXPERIENCE:

• Demonstrated knowledge of cGMP regulations and industry standards related to Pharmaceutical 21 CFR Parts 210 & 211, Dietary Supplement 21 CFR Part 111, and Medical Device 21 CFR Part 820 manufacturing.
• Commitment to quality and continuous improvement.
• Strong sense of ownership and accountability.
• Self-motivated/self-starter
• Strong organizational skills and attention to detail.
• Strong technical writing skills.
• End-to-end project management skills.
• High proficiency in data analysis involving Microsoft Excel.
• Experience applying Lean/Six Sigma problem solving methodologies.
• Excellent verbal and written communication skills.
• Ability to work with minimal supervision, prioritize and manage multiple projects.

EDUCATION:

• Minimum Bachelor’s degree required or 5 years of related experience within FDA-regulated environments. 
• Technical experience and/or degree strongly preferred.

We are an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity or expression, pregnancy, age, national origin, disability status, genetic information, protected veteran status, or any other characteristic protected by law. We are an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity or expression, pregnancy, age, national origin, disability status, genetic information, protected veteran status, or any other characteristic protected by law.