· At least a Bachelor’s degree, in a related field, or equivalent.
· 4-5 years experience in Quality Assurance packaging / pharmaceutical field.
· Demonstrated track-record of accomplishments as a Quality Assurance Manager and with satisfying customers in packaging-driven companies.
· Ability to perform as a manager of job responsibilities.
· Experience with FDA and International Quality System rules and regulations, including planning and implementation.
· Excellent oral and written communication skills, strong interpersonal skills, and superior organizational abilities.
· Ability to read, write, and understand English.
· Excellent personnel management skills required.
· Ability to take initiative, maintain confidentiality, meet deadlines, and work in a team environment essential.
· PC-based computing experience (Word, Excel, PowerPoint, Axcess). AS400 experience preferred.
· IS/9001 Qualifications a plus.
Job Description :
· Confirm that plant audit procedures are properly carried out and assigned work schedules are maintained.
· Determine overall plant project quality by conducting and evaluating various product tests and tests related to components and packaging.
· Resolve major quality problems at QPSI production facilities, warehouses, and market areas as required.
· Evaluate and take corrective action when necessary with regard to product date coding and trade age management at all levels of product movement.
· Educate and instruct plant personnel in recommended quality control testing, equipment sanitation and general sanitation and housekeeping practices. Confirm these procedures are being maintained.
· Consult with plant management and personnel on better operational procedures to improve overall efficiency and project yields.
· Discuss plant evaluation with plant management, make appropriate recommendations and set timetable for improvement and corrections.
· Function as an information source for customers and other QPSI departments when critical quality issues arise.
· Prepare plant evaluation reports and submit them to Corporate QA Director on a monthly basis.
· Assist in development of special department projects and work in conjunction with Corporate QA Director.
· Accept responsibility of training and preparing new employees for this position on a daily basis.
· Develop, maintain, and conduct a review of internal quality systems every quarter, or as required.
· Administrative operation of the Preventative/Correction Action System as needed.
· Support of customer and agency audits.
· Qualification of personnel performing special processes as required by Standard Operation Procedures.
· Quality Assurance input within the approved supplier program.
· Ensuring that documentation and design controls are appropriate for organization.
· Quality Assurance record retention on a daily basis.