BaltimoreRecruiter Since 2001
the smart solution for Baltimore jobs

Senior Quality Specialist (PIP) - Baltimore MD

Company: Kelly
Location: Baltimore
Posted on: April 10, 2021

Job Description:

Senior Quality Specialist (Person in Plant) - Baltimore Maryland Kelly is currently seeking a Senior Quality Specialist for a long-term engagement with one of our Global Pharmaceutical clients. This person will join our Kelly FSP (Functional Service Provider) division, a managed solution provider and business unit of Kelly. This role is full-time and is offering full benefit options. As a Kelly FSP employee you may be eligible for Medical, Dental, Vision, 401K, and a variety of other benefits to choose from. You may also be eligible for paid time off, including holiday, vacation, and sick/personal time. RESPONSIBILITIES:

  • Support the effective and compliant execution of tech transfer activities and development of necessary quality systems at the EM sites and associated off-site storage locations.
  • Support site qualification activities and development of quality agreements in accordance with Company standards.
  • Perform review and approval of equipment and facility qualification, technical documents, raw material specifications, analytical methods, and master batch records to ensure Company products/processes comply with cGMP requirements.
  • Support regulatory submission activities, and lead inspection readiness activities in partnership to support global health authority approvals.
  • Following successful tech transfer, support quality oversight for day-to-day production activities, including deviation and CPA management, escalation of critical issues, and change control.
  • Monitor quality performance and proactively identify risks and mitigation plans through benchmarking and knowledge sharing.
  • Influence and build relationship with internal and external partners to continuously enhance quality culture and business excellence.
  • Interface with other functions (Operations, Planning, Technical Operations, Local Affiliates etc) to meet patient supply requirements
  • Apply cGMP regulations and other FDA and international requirements to all aspects of the position. QUALIFICATIONS: Minimum education required for competent performance:
    • Bachelor's Degree with a concentration in engineering, science, or an equivalent technical discipline
    • Advanced degrees are a plus and may reduce the experience required Minimum experience (number of month/years and type of work experience beyond formal education) required for competent performance:
      • Minimum of 8 years working in an FDA regulated environment Equipment usage and abilities needed:
        • Experience in pharmaceutical aseptic manufacturing operations and quality assurance
        • Detailed knowledge of cGMPs related to pharmaceutical production
        • Strong interpersonal and written/oral communication skills
        • Ability to quickly process complex information and make critical decisions with limited information required
        • Experience in Vaccine Production/ QA
        • Proficient in applying process excellence tools and methodologies
        • Experience working with External Manufacturers or Labs Previous experience with a CMO Ideal candidate will have a blend of QA, QC and Validation experience (QA and Validation are the most critical)" Location:
          • Must be local to Baltimore, MD
          • UP TO 80% time to be on site at External Manufacturer possible. Why Kelly -- ? Kelly-- Science & Clinical is your connection to premier scientific and clinical companies looking to hire talented people just like you. Every day, we match science professionals with dream jobs that fit their skills and interests-it's the way we think job searching should be. Nearly 100 percent of our science recruiters have a professional background/education in science, so we know a thing or two about the science market and how to get you noticed. About Kelly -- At Kelly, we're always thinking about what's next and advising job seekers on new ways of working to reach their full potential. In fact, we're a leading advocate for temporary/nontraditional workstyles, because we believe they allow flexibility and tremendous growth opportunities that enable a better way to work and live (plus, did we mention we provide a ton of benefits ?). Connecting great people with great companies is what we do best, and our employment opportunities span a wide variety of workstyles, skill levels, and industries around the world. Kelly is an equal opportunity employer committed to employing a diverse workforce, including, but not limited to, minorities, females, individuals with disabilities, protected veterans, sexual orientation, gender identity. Equal Employment Opportunity is The Law. ]]

Keywords: Kelly, Baltimore , Senior Quality Specialist (PIP) - Baltimore MD, 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


Supervisor - #267 - Days - Full Time
Description: Location:Sheetz Stores 00267 - 915 EDWARDS FERRY RD NE LEESBURG, VA br br Starting Rate of Pay: 17.00 br Full or Part Time: Full Time br Shift Needed: Days br br SUPERVISOR br br Schedule: (more...)
Company: Sheetz
Location: Leesburg
Posted on: 04/20/2021

Tree Service - Hiring Immediately
Description: Looking for a place where you can thrive br SavATree is a growing tree, shrub and lawn care company. We are looking to add tree climbers and crew leaders with a CDL license preferably to our team (more...)
Company: SavaTree
Location: Leesburg
Posted on: 04/20/2021

Tree Cutter/Groundsman - Hiring Immediately
Description: Looking for a place where you can thrive SavATree is a growing tree, shrub and lawn care company. We are looking to add tree climbers and crew leaders with a CDL license preferably to our team in Sterling, (more...)
Company: SavaTree
Location: Leesburg
Posted on: 04/20/2021


Energetic Nanny
Description: I'm looking for a great nanny for 3 girls ages 4, 3, and 22 months. Animal
Company: Care.com
Location: Leesburg
Posted on: 04/20/2021

Caregiver
Description: Job DescriptionWe are currently offering a Signing/Retention Bonus up to 2,000 Apply to hear more about this great opportunity Home Instead is looking for caring and compassionate CAREGivers to become (more...)
Company: Home Instead
Location: Leesburg
Posted on: 04/20/2021

CDL-A Owner Operator / Lease Purchase Truck Driver Jobs
Description: The Wheels That Move Your Future. When you partner your personal trucking business with CalArk, your success will never be capped. With high weekly miles and
Company: CalArk
Location: Leesburg
Posted on: 04/20/2021

Data Coordinator
Description: Location: Leesburg, VA br Salary: Competitive br Description: Our client is currently seeking a Data Coordinator br br Under general direction, provides general administrative support to a department (more...)
Company: The Judge Group Inc.
Location: Leesburg
Posted on: 04/20/2021

Registered Nurse Intensive Care Unit
Description: Job DescriptionWe are seeking a PRN ICU experienced RN for our Inova Loudoun Hospital. The position would be working night shift. This two time Beacon Award winning ICU is a challenging Medical-Surgical (more...)
Company: Inova Health System
Location: Leesburg
Posted on: 04/20/2021

Lead Supervisor - Leesburg Men's
Description: Coach is a leading design house of modern luxury accessories and lifestyle collections, with a long-standing reputation built on quality craftsmanship. Defined by a free-spirited, all-American attitude, (more...)
Company: Tapestry, Inc.
Location: Leesburg
Posted on: 04/20/2021

CDL A Local Night Jockey Driver w/Tanker - Great Benefits
Description: Richard B. Rudy is now hiring a CDL A Night Jockey Driver What We Offer: Hourly Wage - 20 per hour Health/ Vision/ Dental/ Life Insurance401k profit sharing
Company: Richard B. Rudy
Location: Leesburg
Posted on: 04/20/2021

Log In or Create An Account

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

Baltimore RSS job feeds