Quality Assurance Specialist II

2 weeks ago

Lexington, Kentucky, United States Randstad Life Sciences US Full time

Contract Position

Location: Lexington, MA

Pay Rate: $48-53/hr

Position Overview

The primary responsibilities of this role will concentrate on the daily laboratory functions and the execution of assessments to support manufacturing processes, validation, or developmental studies. Testing may encompass, but is not limited to, samples from drug substance and drug product production, stability assessments, and various protocol studies utilizing approved testing methodologies or those derived from QC technical protocols. The individual may also assist in sampling tasks. This role is expected to uphold operational and GMP readiness of the QC areas, as well as manage critical reagent inventory, including antibodies and cell banks, in appropriate quantities for business needs. Additionally, the individual may engage in more intricate projects, operational excellence initiatives, and various quality systems under general supervision.

Key Responsibilities

  • Receives assignments in the form of objectives and establishes goals to achieve these objectives. Work is assessed based on the accomplishment of objectives and timelines. Recommends and establishes changes to policies affecting subordinate organizations.
  • Percentage of Time and Job Functions
  • 40-50%: Execution of testing, participation in training analysts, troubleshooting methodologies.
  • 20-30%: Support of QC operations, which includes data review, data trending, operational excellence initiatives, maintenance of equipment and reagents, laboratory housekeeping, and support for other QC teams. Compliance and quality systems management (SOP revisions, contributions to quality systems records).
  • 10-20%: Participation in various departmental and cross-functional teams and initiatives; inspection and regulatory support.

Education & Qualifications

  • A bachelor's degree is required, along with 1-2 years of relevant experience (a degree in a science-related field is preferred).

Additional Specific Experience:

  • Strong communication, interpersonal, and organizational skills.
  • Ability to work effectively both independently and collaboratively within a team.
  • Capacity to prioritize tasks and manage multiple responsibilities.
  • Prior experience in a GMP QC role is preferred.
  • Key Skills, Abilities, and Competencies
  • Comprehensive understanding and application of principles, concepts, practices, and standards within the industry. This position requires critical thinking.

Essential Skills:

  • Proficiency in MS Office, LIMS, SAP, Trackwise, compliance, and a strong understanding of scientific principles.
  • Complexity and Problem Solving: Ability to develop solutions to a variety of complex issues. May refer to established precedents and policies. Works on problems of diverse scope where analysis of data requires evaluation of identifiable factors. Demonstrates sound judgment in selecting methods and techniques for obtaining solutions. Networks with senior internal and external personnel in the relevant area of expertise.

Internal and External Contacts

  • Regularly advises, consults, or coordinates with immediate supervisors and other personnel within the section or group. External contacts may include Analytical Development, R&D, Quality Assurance, and other Quality functions, Regulatory, Manufacturing, Facilities, and Engineering.

Other Job Requirements

  • Limited to no travel expected; however, travel between sites may be required.

Physical Requirements:

  • Repetitive bending and reaching to set up and dismantle equipment (if required by specific activities).
  • Ability to work around chemicals (if working in laboratory settings).
  • Ability to wear personal protective equipment such as gloves, gowns, and respiratory protection in certain situations.
  • Ability to walk and stand for extended periods.
  • Participation in environmental chamber monitoring programs may be required, which includes the use of an on-call mobile phone and on-site support during non-business hours.

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