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Quality Assurance Specialist II

4 months ago

Newark, United States Integrated Resources, Inc ( IRI ) Full time

Job Title - Quality Assurance Specialist II

Location - Newark, CA

Duration: 6+ Months


Job Description:

  • The Quality Assurance Specialist II is an intermediate level position with hands-on QA experience.
  • Under moderate supervision, the individual will be working primarily on quality systems, the reserve sample program and incoming attribute inspections.
  • The individual will also assist in quality operations area, such as batch record and quality control data review, line clearances, AQL inspection, and will be interacting with cross-functional groups such as Quality Control, Manufacturing and Regulatory Affairs.

Essential Duties:

  • Perform a wide variety of quality assurance activities to ensure compliance with *** procedures, applicable US and international regulatory requirements for biologic drug substances and drug products under clinical development.
  • Manage the reserve sample program.
  • Perform incoming quality attribute inspections.
  • Coordinate and track closure of the change controls, deviations, quality investigations and CAPAs.
  • Prepare quality system metrics.
  • Review and disposition of incoming raw materials.
  • May support quality operations, as needed (e.g., review executed records such as batch records/ quality control data or equipment qualifications; perform line clearance and product inspection; review other records under supervision such as change control requests, deviations, lab investigations, environmental monitoring excursions, proposed CAPAs).
  • Support continuous improvement of quality systems. Author new, revise existing department procedures and/or forms.
  • Assist in internal compliance audits as needed.
  • Provide inspection readiness support and assist during inspections by regulatory authorities or other third parties.
  • Other duties as assigned.

Work Environment and Physical Demands:

  • This section of the job description is required by the American with Disability Act, (ADA).
  • The ADA requires that job descriptions reflect the physical and mental demands required to effectively perform the essential duties of the job.
  • The ADA prohibits employers from discriminating products a “qualified individual with a disability” in all aspects of the employment relationship.
  • A “qualified individual with a disability” is “an individual who meets the education, experience, skill, and other job-related requirements of a position held or desired, and who, with reasonable accommodation, can perform the essential functions of a specified job.”
  • Prolonged periods of sitting at a desk and working on a computer.
  • Must be able to lift to 10 pounds at times.

Experience:

  • Minimum 4 years’ experience performing quality functions in pharmaceutical and/or biotech related fields.
  • Some working knowledge of quality systems cGMP standards applicable to clinical biologics DS and DP.
  • Works under moderate supervision.
  • Ability to independently analyse and reconcile simple issues.
  • Ability to organize and manage multiple tasks in a fast-paced environment, with minimal instruction on routine work and moderate instructions on new assignments.
  • Good verbal and written communication and interpersonal skills.

Preferred Additional Skills (I.E., Computer):

  • Proficient with commonly used word processing, database systems and other software.