BaltimoreRecruiter Since 2001
the smart solution for Baltimore jobs

Quality Systems Specialist

Company: Paragon BioServices, Inc.
Location: Baltimore
Posted on: June 15, 2019

Job Description:

Paragon Gene Therapy, now a part of Catalent, hires people with a passion to make a difference. Your expertise, coupled with our advanced technologies and collaboration with innovative pharmaceutical, biotech and healthcare companies, will help bring life-enhancing products to the people you know and love. Your talents, ideas and passion are essential to our mission; to develop, manufacture and supply products that help people live better, healthier lives. Paragon Gene Therapy, in Baltimore & Harmans, Maryland, provides industry-leading GMP development and manufacturing services for cutting-edge biopharmaceuticals such as recombinant viral vectors, next generation vaccines & hard-to-express recombinant proteins and oncolytic viruses. This role is responsible for supporting Quality Systems, including investigation/deviation management, CAPA tracking, and change control. This position will facilitate the compiling, trending and reporting key quality metrics for management, and other quality system functions, as needed. Continuously monitor systems and procedures to ensure compliance with applicable regulatory and industry standards, quality improvements, and efficiency for phase appropriate GMP manufacture of biological products. KEY RESPONSIBILITIES:

  • Supports administration for CAPA, Investigation, and Deviation systems. Includes, facilitating the closure of items with the applicable departments to ensure completion and timely resolution.
  • Responsible for tracking and trending aspects of the Quality System and provide reports to management identifying risks and trends on aroutine basis.
  • Performs CAPA effectiveness evaluation based on quantitative and qualitative measurements.
  • Administer the Change Control process for the site and conduct effectiveness verification for changes implemented.
  • Maintains tracking mechanisms to support various Quality Systems elements and ensures visibility throughout the organization
  • Continuously monitor and review systems and procedures for adherence to regulatory compliance, quality improvements, efficiency and industry best practices.
  • Participate in compliance remediation plans and implementation.
  • Assists with the generation and/or revision of GMP documentation such as standard operating procedures.
  • Coordinates on-site client audits, preparation of audit materials, and ensure timely response and resolution to client observations.
  • Assists with performing internal audits.
  • Works cross-functionally with departments to review and improve upon Quality System metrics
  • Participate in site quality and process improvement initiatives. Represent QA on site project teams.
  • Other duties as assigned EDUCATION & EXPERIENCE:
    • Minimum of a B.S. in a Life Sciences discipline
    • 6 years' experience in a GMP environment with at least 4 of those years in a Quality/Compliance function
    • Have the knowledge, and ability to apply basic scientific and regulatory principles to improve quality systems
    • ASQ (American Society of Quality) or RAPS (Regulatory Affairs Professionals Society) highly desirable Paragon Bioservices is proud to be an Equal Employment Opportunity and Affirmative Action employer. We do not discriminate based upon race, religion, color, national origin, gender (including pregnancy, childbirth, or related medical conditions), sexual orientation, gender identity, gender expression, age, status as a protected veteran, status as an individual with a disability, or other applicable legally protected characteristics. #LI-EW1

Keywords: Paragon BioServices, Inc., Baltimore , Quality Systems Specialist, Other , Baltimore, Maryland

Click here to apply!

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

I'm looking for
in category
within


Other Other Jobs


Telecommute Business Development Specialist
Description: Are you seeking a career that will allow you the ability to work from home with a greater earning potential TeleReach Corporate offers both. As a Business Development Representative with TeleReach, you (more...)
Company: TeleReach Corporate
Location: Leesburg
Posted on: 06/20/2019

Currently Interviewing!
Description: We are seeking career and goal driven individuals to work with our expanding Healthcare company.
Company: AmeriPlan USA
Location: Chantilly
Posted on: 06/20/2019

Travel Nurse RN - Surgical ICU Stepdown - $1,591.00 per week
Description: NurseFly Travel Nursing with Stability Healthcare is seeking a travel nurse RN Surgical ICU Stepdown for a travel nursing job in Leesburg, VA: br br br ul br li Specialty: Surgical ICU Stepdown (more...)
Company: NurseFly Travel Nursing
Location: Leesburg
Posted on: 06/20/2019


Systems Integrator II
Description: Systems Integrator II Overview Every day at Perspecta, we enable hundreds of thousands of people to take on our nation's most important work. We're a company founded on a diverse set of capabilities and (more...)
Company: Perspecta
Location: Chantilly
Posted on: 06/20/2019

Decision Analytics Developer
Description: Integrity Applications Incorporated IAI is a software and system engineering company headquartered in Chantilly, Virginia with offices Nationwide. IAI has been selected as one of the best companies (more...)
Company: Integrity Applications Incorporated
Location: Chantilly
Posted on: 06/20/2019

Automotive Sales Associate
Description: br br Automotive Sales Associate 6079 br br br br Job Location br br br br Chantilly, VA br br br br Employment duration br br br br Full time br br br br (more...)
Company: Apco
Location: Chantilly
Posted on: 06/20/2019

Vineyard Laborer
Description: Breaux Vineyards is looking for strong laborers to work in the vineyards. He/She must be
Company: Breaux Vineyards
Location: Leesburg
Posted on: 06/20/2019

Work at home opportunity - PT/FT
Description: Currently interviewing for part-time and full-time health plan specialists and recruiters for a national
Company: Careers Division
Location: Chantilly
Posted on: 06/20/2019

Watch Operator - Chantilly
Description: Overview Peraton has a great opportunity for Watch Operator, supporting our government customer. Responsibilities What you'll do... Provide operational support to mission critical systems including receiving, (more...)
Company: Peraton
Location: Chantilly
Posted on: 06/20/2019

Systems Integration Engineer-SECRET REQUIRED
Description: Job Description: br br Employer is seeking a Systems Integration Engineer for a mission critical program in Chantilly, VA. The integration engineer will apply technical knowledge and project management (more...)
Company: Leidos
Location: Chantilly
Posted on: 06/20/2019

Log In or Create An Account

Get the latest Maryland jobs by following @recnetMD on Twitter!

Baltimore RSS job feeds