Contract Quality Systems Manager.794-4195 Job at Frink-Hamlett Legal Solutions, Exton, PA

VU9Xc0F6S0dKNEkvcm9ULyswaXNmU3o0NFE9PQ==
  • Frink-Hamlett Legal Solutions
  • Exton, PA

Job Description

The Opportunity:

Global pharmaceutical company in Exton, PA seeks a Contract Quality Systems Manager to join their team. This is a long-term, temporary position, Monday - Friday, 40 hours per week. The position is hybrid in Exton, PA and the hourly rate is $70 plus benefits.

Primary Duties:

The Contract Quality Systems Manager responsible for maintaining and improving Quality Systems for the company's region to ensure on-going compliance with applicable compendia, GMP’s, and Regulatory guidance. The Quality Systems include quality risk management, documentation, global and local auditing, health authority inspection management, training, event management (deviations, complaints, CAPA), and change control (global and local). The Contract Quality Systems Manager will interface with Quality System personnel in other sites. The Contract Quality Systems Manager will serve as a subject matter expert (SME) for GMP and Data Integrity (DI) requirements. Must effectively work as a team with internal customers, peers, and management through effective oral and written communication. Must evaluate the compliance of records, documents, and Quality Systems to ensure that the site is operating per GMP and DI requirements. Additional duties include the following:

  • Collaborate and provide expert reviews to ensure records, documents, and Quality Systems meet GMP and DI requirements (promote quality, DI, and GMP awareness).
  • Support external and internal audits for the company's sites.
  • Contribute to the oversight of Quality Systems core responsibilities (track, report, adjust) by trending quality metrics for the company's sites.
  • Develop and manage processes that ensure the Exton site remains in compliance with global quality polices, regulatory requirements, and industry requirements, including periodic review and consolidation.

Requirements:

  • Bachelor’s degree (preferably in science related discipline) preferred
  • 5 – 7 years of experience working with Quality Systems (Deviation, Change Control, CAPA, audit, etc.)
  • Demonstrated proficiency and experience in working with Quality Systems IT applications
  • Training within a regulated pharmaceutical/biotech/medical device environment
  • Understanding and application of CGMP’s (EU, JP, US)
  • Detailed knowledge and application with electronic Quality Systems (i.e. TrackWise, Documentum
  • Strong attention to detail as demonstrated through consistent quality of work
  • Excellent written and verbal communication skills
  • Computer proficiency in MS Word and Excel, Project and Visio required;
  • ​Strong project management skills are preferred
  • Timely follow up to ensure satisfactory resolution to issues
  • Knowledge of CGMPs (relevant laws, guidance, directives and industry practice), and demonstrated ability to apply learnings appropriately
  • Ability to work in a controlled environment

The Partnership – Benefits:

  • ABA - MEC Medical Benefit
  • PEP 401kPaid
  • Time Off
  • Employee Assistance Program (EAP)
  • Working Advantage {discounts)
  • Financial Wellness Program (FinFit)

Frink-Hamlett Legal Solutions is an equal employment opportunity employer and all qualified applicants will receive consideration for employment without discrimination based on race, color, creed, national origin, sex, age, disability, marital status, sexual orientation or citizenship status.

Job Tags

Hourly pay, Contract work, Temporary work, Local area, Monday to Friday,

Similar Jobs

Anveta, Inc

HVAC Installer Job at Anveta, Inc

 ...Responsibilities Install and Commission HVAC/R equipment following company policies and manufacturer instructions. Troubleshoot and resolve equipment issues to ensure proper operation. Complete installations within allocated timeframes while maintaining high quality... 

Native American Rehabilitation Association of the Northwest,...

Behavioral Health Care Coordinator **$5,000 Sign On Bonus** Job at Native American Rehabilitation Association of the Northwest,...

 ...Title: Behavioral Health Care Coordinator Location: 703 NE Hancock St. Portland, OR 9721 Schedule: This is an In-person position, Monday through Friday, 8:00am 4:30pm Wage Range: $34.61 $40.87 , Non-Exempt, Hourly **$5,000 Sign On Bonus** If you are... 

Akkodis

Windows Engineer Job at Akkodis

 ...migrating applications from lower version of dot net and IIS to a higher version is a good to have Experience with tools like Autosys, Splunk, Wireshark, WinSCP, OpenSSH & any static content distribution tools are added advantage Pennington If you are... 

Capstone Logistics, LLC

Enterprise Software Developer Job at Capstone Logistics, LLC

 ...JOB SUMMARY: This role will play a critical role in supporting and enhancing the organizations technology infrastructure. Your responsibilities...  ...are incorporated into the design and architecture of software programs. Establish and maintain automated testing... 

EZJobs

CNC Programmer Job at EZJobs

 ...looking for a CNC CAM Programmer to join our Grand River, OH team! Exceptional Benefits Outstanding Medical Insurance with $0 deductible option Dental, and Vision Insurance Paid Vacation, Personal Time and Holidays 401(k) Employer Match, $ for $ up to...