LakewoodNJRecruiter Since 2001
the smart solution for Lakewood jobs

Quality Compliance Sr. Specialist

Company: Renaissance Pharmaceuticals
Location: Lakewood
Posted on: July 2, 2019

Job Description:

Quality Compliance Sr. Specialist OverviewSupport Quality Compliance objectives to ensure compliance to state, federal, and other requirementsQuality Compliance Sr. Specialist Responsibilities


  • Plan, conduct and document internal audits. Evaluate findings and report these to the respective department and upper management. Assure implementation of any resulting corrective action plans. Use the internal audit program to assess the level of Renaissance's compliance with applicable cGMP, QSR and pertinent standard operating procedures (SOPs).
  • Plan, conduct and document external audits (Raw Materials, Contract Laboratory, Sterilization facilities, etc.). Evaluate findings and report these to the respective companies and Renaissance management. Assure implementation of a any resulting corrective action plans.
  • Assist with on-site cGMP audits performed by, or on behalf of, clients and potential clients. Represent Renaissance Quality Systems and facilitate interactions between client and Renaissance personnel during the audit. Assist with the management of observations and corrective actions in Trackwise. Prepare or assist with responding to client observations in accordance with Renaissance SOPs.
  • Manage and prepare client submission documents retrieved from supporting departments.
  • Assist in responding to deficiency letters received from the agency.
  • Represent Quality Compliance on client conference calls for submission readiness and support.
  • Complete site reviews of compendia and guidance updates.
  • Prepare Annual Product Reviews or Product Quality Reviews for products produced at the Lakewood site.
  • Support upper management in preparation for, during, and following regulatory agency inspections.
  • Prepare and update drug listings for the Lakewood site.
  • Work with outside contracting site to maintain licenses/registrations within each state's requirements.
  • Prepare Annual Reports for each state as required and working with vendor for state licensing. Maintain vendor Licensing Database Tracking system.
  • Maintain and knowledge of cGMP (US/EU/Canada) and company operating procedures and policies.
  • Perform other duties as assigned.
  • Understand and comply with all Renaissance safety, environmental and quality practices and procedures as outlined in organizational/departmental guidelines and SOPs as well as applicable federal, state and local regulations.

    Quality Compliance Sr. Specialist QualificationsBachelor's Degree (BA or BS) required. A minimum of six years of related experience and/or training is required.PI111440712

Keywords: Renaissance Pharmaceuticals, Lakewood , Quality Compliance Sr. Specialist, Other , Lakewood, New Jersey

Click here to apply!

Didn't find what you're looking for? Search again!

I'm looking for
in category
within


Other Other Jobs


CDL A Truck Drivers - Owner Operators - AMAZING PAY - Call Or Apply Today. (West Babylon)
Description: Our top drivers earned 180,000 in 2017DRY VAN DIVISIONPay is 72 plus 100 fuel surcharge- 2.00 per mile average including FSCDispatched from Valparaiso, INRuns only east of the Mississippi River/Also, (more...)
Company: Star Freight
Location: West Babylon
Posted on: 07/22/2019

Regional CDL A Truck Drivers - Home Weekends!.
Description: CDL Driver Class A - RegionalPaul Miller Trucking 1400 Weekly SalaryAt Paul Miller Trucking we respect our drivers needs and want to make sure that you have safe and reliable equipment to work with. We (more...)
Company: PAUL MILLER TRUCKING
Location: White Plains
Posted on: 07/22/2019

Looking To Hire Owner Operator CDL A Truck Drivers
Description: Our top drivers earned 180,000 in 2017DRY VAN DIVISIONPay is 72 plus 100 fuel surcharge- 2.00 per mile average including FSCDispatched from Valparaiso, INRuns only east of the Mississippi River/Also, (more...)
Company: Star Freight
Location: West Babylon
Posted on: 07/22/2019


CDL A Truck Drivers - Owner Operators - AMAZING PAY - Call Or Apply Today. (White Plains)
Description: Our top drivers earned 180,000 in 2017DRY VAN DIVISIONPay is 72 plus 100 fuel surcharge- 2.00 per mile average including FSCDispatched from Valparaiso, INRuns only east of the Mississippi River/Also, (more...)
Company: Star Freight
Location: White Plains
Posted on: 07/22/2019

Local CDL A Intermodal Owner Operator Truck Drivers!.
Description: Looking for Local/Regional CDL A Owner Operator Truck Drivers Position Based Out Of Kearny, NJ Intermodal - Haul from the rail ramp to surrounding
Company: Blue and Grey Transport
Location: White Plains
Posted on: 07/22/2019

Looking To Hire Owner Operator CDL A Truck Drivers
Description: Our top drivers earned 180,000 in 2017DRY VAN DIVISIONPay is 72 plus 100 fuel surcharge- 2.00 per mile average including FSCDispatched from Valparaiso, INRuns only east of the Mississippi River/Also, (more...)
Company: Star Freight
Location: White Plains
Posted on: 07/22/2019

Data Scientist
Description: As one of the original innovators in lending, credit, fraud, and spend analytics, Verisk Financial integrates one of the industry's largest sets of data to help banks, financial regulators, retailers, (more...)
Company: Argus Information and Advisory Services
Location: White Plains
Posted on: 07/22/2019

Local CDL B Truck Drivers - $1,500 Sign On Bonus!. - White Plains
Description: Party Rental Ltd. is now hiring Local CDL B Truck Drivers in Teterboro, NJ What We Offer: 1,500 Sign On Bonus Competitive Pay Great Benefits Package: Health, Medical, Dental, VisionLife Insurance401k (more...)
Company: Party Rental
Location: White Plains
Posted on: 07/22/2019

CDL A Truck Driver - $.70 CPM - Earn Over $72k!. (White Plains)
Description: OTR Dry Van and Flatbed Positions Available Company Driver:Over 72k year earning potential for company drivers. 1500 to 2100 per week depending if driving flatbed or dry van..70 per mileOur drivers (more...)
Company: Forward Freight Systems
Location: White Plains
Posted on: 07/22/2019

CDL A Lease Purchase Truck Drivers
Description: Our top drivers earned 180,000 in 2017DRY VAN DIVISIONPay is 72 plus 100 fuel surcharge- 2.00 per mile average including FSCDispatched from Valparaiso, INRuns only east of the Mississippi River/Also, (more...)
Company: Star Freight
Location: White Plains
Posted on: 07/22/2019

Log In or Create An Account

Get the latest New Jersey jobs by following @recnetNJ on Twitter!

Lakewood RSS job feeds