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Quality Assurance Specialist

  • Location: Massachusetts
  • Job Type:Contract

Posted 4 days ago

  • Expiry Date: 13 June 2022

Job Description:

Major duties and responsibilities:

  • Ensure product compliance with current specifications, procedures, validation requirements.

  • Provides document review and approval of facility, equipment, and utility commissioning and qualification to ensure compliance with policies and procedures.

  • Ensures that all regulatory and cGMPs compliance items related to validation are satisficed and ensures Validation Master Plan (VMP) adherence.

  • Reviews and approves protocol discrepancies associated with the qualification and start of of the Facility.

  • Identifies unresolved issues/decisions related to validation documents and escalates as appropriate.

  • Document errors found during the auditing process and assure adequate corrections are documented.

  • Categorizes and reports documentation errors and deviations in order to notify management of trends and focus on the required corrective measures.

  • Provides input to management on the need for revision of manufacturing/validation protocol instructions based on trends, documentation errors or supplemented information.

  • Participate in Regulatory and Compliance audits FDA, DEA, EU, etc as needed.

  • Exercise leadership, team skills, self confidence, and effective decision making throughout projects.

  • Other duties as assigned by manager

Education:

  • B.S. in a scientific or engineering discipline.

Experience / Knowledge Desired:

  • A minimum of 4 years of experience in an environment governed by cGMPs.

  • Knowledge of cGMP and regulatory requirements for validation of equipment, computerized systems, and processes.

  • Proficiency in the use of computers and software applications including electronic validation systems and electronic change control systems - prior experience with applicable business systems including Valgenesis, LIMS, Maximo, and Veeva Vault are desirable.

  • Able to rapidly adapt to changing environments and circumstances requiring flexibility, tolerance and great sense of urgency while ensuring that all cGMP and Regulatory requirement are met.

  • Must exercise accurate judgment and be able to evaluate information critically and decide upon appropriate course of action.

  • Must be able to correlate events and determine the action plan required to avoid incidents recurrence and or regulatory exposure.

  • Good verbal and written communication skills are essential.

  • Excellent interpersonal skills at every level.

  • Capable of managing multiple priorities.

About ASK: ASK Consulting is an award-winning technology and professional services recruiting firm servicing Fortune 500 organizations nationally. With 5 nationwide offices, two global delivery centers, and employees in 42 states-ASK Consulting connects people with amazing opportunities.

ASK Consulting is an equal opportunity employer. We celebrate diversity and are committed to creating an inclusive environment for all associates.