Quality Specialist Supporting Clinical Supplies/Pharmaceutical

30 Jun 2024

Vacancy expired!

QUALITY SPECIALIST SUPPORTING CLINICAL SUPPLIES/PHARMACEUTICAL RAHWAY, NJ Project Description:

  • The Quality Specialist will be responsible for serving as the quality representative for and providing quality oversight of contractors performing various GMP activities supporting the production of clinical supplies, on behalf of our Company.
  • Managing the quality oversight of nominated Third-Party Vendors in the Clinical Finished Goods (FG) Platform.
  • Leading internal contractor related issue investigation and resolution teams, review and approval of contractor-initiated investigations associated with deviations, negotiation of site and global Technical and Quality Agreements, assisting in audit finding/CAPA closure of contractor GMP audits.
  • The position will be heavily involved in close collaboration with external contractor quality and technical personnel.
  • Internally interacting closely with Quality Disposition, Pharmaceutical Research/Development and Procurement on strategic objectives-utilizing external contractors including GMP qualification as well as site/project selection.
  • Makes independent decisions and acts with authority to carry out required actions.
  • Identifies and leads implementation of Contractor and Supplier System improvements.
  • Including trends and/or potential compliance gaps and proactively leads the resolution of long-standing or significant issues.
  • Leads communication, and serves as the quality spokesperson, on a variety of quality or compliance-related issues.
Required Skills:
  • Bachelor's Degree in Pharmacy, Biology, Engineering, Chemistry or related field.
  • At a minimum this position requires a bachelor's degree with a minimum of 5 years of relevant experience within the pharmaceutical industry.
  • Strong scientific/ technical knowledge and experience in R&D activities, coupled with the ability to interact with scientific subject matter experts on various product initiatives and issues in the following areas: Clinical Packaging and Labelling, Distribution of clinical supplies.
Preferred Skills:
  • Strong compliance knowledge of regulations coupled with proficiency in interpreting and applying GMPs to a R&D environment, especially related to Investigational Medical Products, finished goods and packaging.
  • Demonstrated project management experience as well as developing key quality metrics.
  • Demonstrated time management skills, ability to conduct well defined projects within discipline or area of expertise.
  • Strong scientific/ technical expertise, perspective and judgment in the selected subject matter area coupled with the ability to interact with scientific subject matter experts on various product initiatives.
  • Strong understanding of regulatory agency regulations and requirements.
  • Ability to independently interact with regulatory officials and external auditing parties.
  • Possess deep drug development knowledge; recognize improvement opportunities, develop appropriate solutions and follow " through on implementation.
  • Strategic view of project issues in a quality systems environment.
  • Strongly developed cross-functional teamwork, collaboration and negotiation skills.
  • Demonstrated skills in communicating (oral and written) effectively with diverse colleagues/groups.
  • Demonstrated skills in leadership; operational planning (3 months to 1year span); integrating, managing, and/or coordinating similar/ related teams, units, work processes or functions.
This 12+ month position starts ASAP. Please E-MAIL your resume (attachment to email) with rate and availability to Bridget: ALPHA'S REQUIREMENT #22-01918 MUST BE ELIGIBLE TO WORK IN THE U.S. AS AN HOURLY W2 EMPLOYEE

  • ID: #43715199
  • State: New Jersey Rahway 07065 Rahway USA
  • City: Rahway
  • Salary: BASED ON EXPERIENCE
  • Job type: Contract
  • Showed: 2022-06-30
  • Deadline: 2022-08-28
  • Category: Et cetera