Job Summary
- Company
- J. Knipper & Company
- Location
- Lakewood, NJ 08701
- Industries
- Biotechnology/Pharmaceuticals
- Job Type
- Full Time
- Employee
Manager, Quality Assurance
About the Job
Are you looking for a position with a dynamic healthcare marketing company that offers career advancement and professional development? J. Knipper and Company, is an established marketing firm located in Lakewood, NJ. Join J. Knipper's team and be part of the healthcare industry's preferred partner for marketing solutions.
This position requires the qualified candidate to plan and direct the quality assurance program. The successful candidate in the role will have the following key responsibilities: Manages and directs the QA function and SOP Management. Candidates must have the ability to work with Operations management and Regulatory Affairs regarding compliance initiatives, assessment, risk analysis, customer and agency audits. Must review client Quality Agreements, prepare QC Release forms and Certificates of Compliance. Will monitor inspection activities, issue deviation reports and understand the impact of the deviations related to systems developed by IT. Provides SOP and GMP training. Responsible for follow up alerts from temperature and humidity monitoring systems and charts, calibration of temperature recorders, shipping scales and bar code scanners. Conducts trending analysis and leads the Quality Council meetings. Tracks and files client adverse event reports. Directs corrective and preventative action (CAPA) process. Must work closely with Facilities Management team to oversee pest control program and conduct audits.
Supervisory Management responsibilities include: Direct supervision over QA Supervisor and QA Associates, as well as, interviewing, hiring, training employees; and directing work of staff members.
Must have a Bachelors Degree and five to seven years QA management experience. Exceptional communication and writing skills, are required. Must be proficient in math, basic statistics, and MS Office products. Must have the ability to learn new business and warehouse management software/systems. A working knowledge of cGMP, PDMA, DEA regulations is required. Familiar with ANSI sampling standards.
We offer a comprehensive benefits package including medical, dental, life, vision, LTD, AD&D, FSA and a 401(k) Savings Plan.
Send resume with salary requirements to: J. Knipper and Company, One Healthcare Way, Lakewood, NJ 08701, Attn:HR. You can also e-mail your resume with salary requirements to HR@Knipper.com or fax to (732)370-3747.
EOE M/F/D/V
This position requires the qualified candidate to plan and direct the quality assurance program. The successful candidate in the role will have the following key responsibilities: Manages and directs the QA function and SOP Management. Candidates must have the ability to work with Operations management and Regulatory Affairs regarding compliance initiatives, assessment, risk analysis, customer and agency audits. Must review client Quality Agreements, prepare QC Release forms and Certificates of Compliance. Will monitor inspection activities, issue deviation reports and understand the impact of the deviations related to systems developed by IT. Provides SOP and GMP training. Responsible for follow up alerts from temperature and humidity monitoring systems and charts, calibration of temperature recorders, shipping scales and bar code scanners. Conducts trending analysis and leads the Quality Council meetings. Tracks and files client adverse event reports. Directs corrective and preventative action (CAPA) process. Must work closely with Facilities Management team to oversee pest control program and conduct audits.
Supervisory Management responsibilities include: Direct supervision over QA Supervisor and QA Associates, as well as, interviewing, hiring, training employees; and directing work of staff members.
Must have a Bachelors Degree and five to seven years QA management experience. Exceptional communication and writing skills, are required. Must be proficient in math, basic statistics, and MS Office products. Must have the ability to learn new business and warehouse management software/systems. A working knowledge of cGMP, PDMA, DEA regulations is required. Familiar with ANSI sampling standards.
We offer a comprehensive benefits package including medical, dental, life, vision, LTD, AD&D, FSA and a 401(k) Savings Plan.
Send resume with salary requirements to: J. Knipper and Company, One Healthcare Way, Lakewood, NJ 08701, Attn:HR. You can also e-mail your resume with salary requirements to HR@Knipper.com or fax to (732)370-3747.
EOE M/F/D/V
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J. Knipper & Company
