This job has expired

Engineering Compliance & Documentation Specialist IV

Employer
University of Massachusetts Medical School
Location
460 Walk Hill Street

View more

Administrative Jobs
Institutional & Business Affairs, Assessment, Accreditation & Compliance
You need to sign in or create an account to save a job.

Job Details

Overview

GENERAL SUMMARY OF POSITION:

Reporting to the Senior Director Engineering or delegate, the Engineering Compliance and Documentation Specialist IV will be 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: supporting audits, designing and executing programs, data and documentation reviews and analysis.

Responsibilities

MAJOR RESPONSIBILITIES:

  • Works with other Department representatives to implement and maintain GMP documentation and record filing procedures for Facilities, Engineering and Validation.
    • Facilitate the review and approval of deviation reports, CAPAs and RTs, ensures compliance with SOPs and Regulations.
    • Evaluates Facilities and Engineering documentation for consistency to Engineering Guidelines and cross functional consistency.
    • Evaluates change controls for closure; ensures required tasks are completed.
    • Issues periodic Facilities and Engineering Quality System Metrics
  • Uses Good Engineering Practices to manage Engineering Documentation at MassBiologics.
  • Creates formats for GMP related documentation including SOPs, forms and other master documents
  • Creates and organizes systems for filing and tracking Engineering Documentation / GMP related records.
  • Manages communication with third parties for MassBiologics during execution of capital projects, including specification, drawings submittals and RFIs
  • Edits and revises master documents for cGMP operations including SOPs, forms, protocols, reports after receiving from QA Documentation.
  • Issues and distributes SOPs, forms, and protocols.
  • Maintains documentation Access database.  Creates electronic tracking systems for completed records
  • Reviews documents to ensure GMP documentation meets in-house and GMP requirements.
  • Tracks and follows-up on periodic review process for SOPs and IPEN forms
  • Maintains Index for commissioning documentation and related equipment turnover packages.
  • Provides training for VAL, EN, FAC Documentation staff and other department personnel on all SOP, IP, GMP procedures
  • Assists in the organization of validation packages and technical reports.
Qualifications

REQUIRED QUALIFICATIONS:

  • Requires a Bachelors degree or equivalent with a minimum of 8 years of related experience in documentation, engineering technical writing or equivalent.
  • Normally receives no instructions on routine work, general instructions on new assignments.
  • Computer literate and in-depth knowledge of MS Office programs. Must have a working knowledge of design of relational databases.
  • Works on problems of diverse scope where analysis of situation or data requires a review of identifiable factors. Exercises judgment within defined practices and policies in selecting methods and techniques for obtaining solutions.
  • Must have excellent verbal and written communication skills. 
  • Ability to focus on detail while still retaining concept of large picture
  • Ability to work independently and to prioritize work
  • Excellent proof reading skills
  • Attention to detail is critical
  • Must be able to learn technical details associated with Validation protocols and Engineering SOPs.
  • Must be able to follow all current Good Manufacturing Practices.
  • Willingness to learn new software systems.  Limited travel for training purposes is required.

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

Find Us
Location
United States
You need to sign in or create an account to save a job.

Get job alerts

Create a job alert and receive personalised job recommendations straight to your inbox.

Create alert