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Quality Assurance Compliance Specialist IV, Senior

Employer
University of Massachusetts Medical School
Location
460 Walk Hill Street

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Administrative Jobs
Institutional & Business Affairs, Assessment, Accreditation & Compliance
Employment Type
Full Time
Institution Type
Four-Year Institution
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Job Details

Overview

 

GENERAL SUMMARY OF POSITION:

 

The QA Compliance Specialist IV, Senior level position is responsible for ensuring that quality standards are met in a cGMP Biologics Manufacturing facility by performing a wide variety of activities to assure compliance with applicable regulatory requirements. These activities include, but are not limited to: conducting audits, designing and executing programs, data and documentation reviews and analysis

Responsibilities

MAJOR RESPONSIBILITIES:

 

  • Facilitate the review and approval of deviation reports; ensures appropriate corrective actions are assigned.
  • May be responsible for managing the development, implementation and maintenance of Quality Assurance Training systems and activities. Assures training is conducted and documented per GMP requirements. 
  • Develops and manages GMP orientation program and ongoing GMP training for all GMP related departments.
  • Processes change controls for closure; ensures required tasks are completed.
  • Plans and conducts audits of co-manufacturers and vendors
  • Plans and conducts periodic internal audits of production and laboratory areas.  Writes audit reports.
  • Reviews completed batch records, related records, and validation packages for compliance to cGMPs and internal requirements.   Reviews and approves SOPs, in-process forms, and validation protocols.
  • Reviews audit findings and completion of corrective actions.  Provides periodic reports to management regarding status of audits and corrective actions.
  • Prepares annual product reports.
  • Applies knowledge and understanding of current regulations to make recommendations to senior staff.
  • Performs additional job related duties as required
Qualifications

REQUIRED QUALIFICATIONS:

 

  • Requires BS degree in a scientific discipline or equivalent and a minimum of 8 years relevant experience or equivalent
  • Prior experience in a cGMP regulated environment. Strong working knowledge of GMPs and Quality systems, and thorough understanding of how cGMP regulations and guidances apply to investigational and market licensed biologics
  • Demonstrated ability to train and supervise others
  • Ability to conduct complex troubleshooting
  • Ability to assess issues and make Quality decisions of a moderate scope within established procedures and policies.
  • Working knowledge of current Good Manufacturing Practices and Quality Assurance systems
  • Must possess the ability to interpret and apply current GMP regulations and internal Quality policies consistently.
  • Computer literate and knowledge of WordPerfect or MS Word, and Lotus or Excel.  Demonstrated skills in developing and organizing systems for management of information. 
  • Demonstrated ability to meet deadlines, multitask, and change priorities while maintaining productivity.
  • Ability to work well independently and in a team environment
  • Demonstrated excellent verbal and written communication skills

Organization

Realize Your Opportunities – A Career at UMASS Medical School

Inside Workings at UMASS Medical School

The University of Massachusetts Medical School (UMMS), the Commonwealth's only public medical school, is proud of our role in serving the people of Massachusetts. Although, its the inside workings of UMMS that makes the difference.

Mission and Culture

  • We’re serious about our mission and about our people. 
  • Real World Impact - Our people get excited about our mission of real-world impact in health sciences education, research and public service.
  • International Prominence and New Opportunities - As this institution has grown to national – and international – prominence, we’ve found new opportunities to train tomorrow’s physicians, nurses and scientists,  discover causes of and cures for disease and help improve the quality of health care.
  • Deep Commitment - With our clinical partner, UMass Memorial Health Care, and our other teaching affiliates, we share a deep commitment to national distinction in patient care.
  • Valued Partnerships – UMMS partners with Commonwealth Medicine, the health care consulting arm of UMMS. Also, UMMS partners with MassBiologics in scientific collaborations, technology management and creating partnerships for the development of products for the benefit of patients.  These valued partnerships help us to provide services and programs to help meet our needs at UMMS and the public.
  • Proud Contributors - People at UMMS enjoy the feeling of going to work every day knowing what they do is truly important and worthwhile.
  • Complementary and Inseparable - These varied parts of our mission and culture are complementary and inseparable.                 

Careers

UMMS, the state’s first and only public academic health sciences center, educates physicians, scientists and advanced practice nurses to heal, discover, teach and care, with compassion.  UMMS is a world-class institution with opportunities to match. 

Competitive Compensation – UMMS offers salaries that are competitive with Worcester-area employers. When combined with our generous benefits, perks, and paid time off, many job seekers are surprised to find a total rewards package that matches or exceeds their current situation.

Targeted Hiring Process – At UMMS, there are actually multiple hiring processes for different segments of our workforce.  In nearly all cases, UMMS hiring process is decentralized, with qualified candidates screened and referred to an academic officer or manager with hiring authority.

24/7 Access to Employment Opportunities – iCIMS is our online job search and application system.  iCIMS is available 24/7 to provide you with a convenient and up-to-date view of the available employment opportunities across our campuses. Updates are made daily and include all faculty and non-faculty position listings from every school and department within the UMMS. When you identify a position you are interested in and qualified for, apply online. New opportunities become available frequently so it pays to check back often!

Benefits

With outstanding benefits, competitive pay, extensive learning opportunities, and a stimulating and attractive work environment, UMMS may be exactly the employer you’ve been looking for.

• Superior Benefits - UMMS offers a wide range of benefits and perks that invite comparison with the best employers in the Worcester area – and with academic institutions anywhere. UMMS provides superior medical and dental coverage for you and your family, fully funded retirement plans, generous time off, a Tuition Assistance Plan – and much more.

• People Centered - UMMS is an employer, but it is also a community. Its comprehensive medical and dental benefits, retirement plans, and even paid holidays reflect an institution built around people, with a deep respect for their differences and needs.

• Commitment to Healthy Living - UMMS provides resources to help you balance work and life and encourages healthy living through great programs and discounts for fitness, physical activity, weight management, nutritional counseling and general wellness available through our health insurance plans.

• Breadth of Offerings - Above all, the breadth of UMMS offerings set the School apart and makes it an environment favored by all sorts of smart, career-savvy people.

Apply for a Job

As an equal opportunity and affirmative action employer, UMMS recognizes the power of a diverse community and encourages applications from individuals with varied experiences, perspectives and backgrounds.

Online - To view all job opportunities and apply online, visit www.umassmed.edu/hr and click on the “Careers” tab.

Start Now and Realize Your Opportunities!

A History of Making Vital Improvements - UMASS Medical School Milestones

1962: Legislation establishes University of Massachusetts Medical School
1970: First medical students begin classes in Shaw Building
1974: First class graduates 16 MDs
1979: PhD program begins
1986: Graduate School of Nursing opens
1986: PhD program becomes Graduate School of Biomedical Sciences
1994: Graduate School of Nursing initiates PhD program
1998: UMass Clinical System and Memorial Health Care merge to form UMass Memorial Health Care
2001: Lazare Research Building opens
2002: Campus Modernization begins on the University Campus
2004: Graduate Entry Pathway Program established at the Graduate School of Nursing
2005: PhD Program in Clinical & Population Health Research established at the Graduate School of Biomedical Sciences
2005: Massachusetts Biologic Laboratories opens new manufacturing and filling facility in Mattapan
2006: Craig Mello, PhD, Blais University Chair in Molecular Medicine and Howard Hughes Medical Institute Investigator, is awarded the Medical School's first Nobel Prize. Dr. Mello shared the 2006 Nobel Prize in Physiology or Medicine with Andrew Fire, PhD, of Stanford University, for their discoveries related to RNA interference.
2007: Michael F. Collins, MD, is named chancellor and Terence R. Flotte, MD, is named dean of the School of Medicine.  
2009: Groundbreaking for the Albert Sherman Center, a 500,000-square-foot research and education facility slated for completion in 2012.
2010: Ambulatory Care Center opens
2012: The Albert Sherman Center, a 500,000-square-foot research and education facility, completed and opens

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