Sr. R&D QA Specialist

Location
San Francisco, CA, United States
Posted
Feb 10, 2021
Ref
5061-545-R
Hotbed
Biotech Bay
Required Education
Bachelors Degree
Position Type
Full time
Position Overview

Nektar has an exciting opportunity for a Sr. R&D QA Specialist to join their team.

Performs the coordination and preparation of internal and external audits to assure compliance to internal procedures, policies and standards, as well as all relevant State, Federal and International regulations. Identifies compliance risks and develops sound rationale as basis for the observations. Collaborates with clients to develop positive and proactive approaches to regulatory compliance. Informs functional area personnel and management on current regulatory compliance information such as new regulations, guidance documents, regulatory inspections, initiatives etc. Audits reports and data supporting clinical/preclinical components of regulatory submissions Participates in GXP (GCP/GVP/GLP) training of functional areas and assists in the development of training sessions. May coordinate activities and assist with interactions during regulatory agency inspections. May have direct interaction with regulatory agencies on defined matters. May administer and manage quality system metrics. Applies knowledge of good clinical, pharmacovigilance, and laboratory practices on a daily basis. This position contributes to and supports the company's research and development efforts to create high value therapeutics to address unmet medical needs.
  • Works on significant and unique issues where analysis of situations or data requires an evaluation of intangibles. Exercises independent judgment in methods, techniques, and evaluation criteria for obtaining results. Creates formal networks involving coordination among groups.
  • Performs QA review of all records related to clinical trials.
  • Analyzes and evaluates common errors found in document review and reports to QA management. • Develops internal, investigator site and CRO audit plans, checklists and schedules.
  • Performs internal, investigator site and CRO audits; guides auditee(s) to accomplish regulatory compliance.
  • Prepares and communicates internal, investigator site and CRO audit reports.
  • Supports QA review of all records related to the assessment of quality system performance to regulatory requirements.
  • Evaluates corrective and preventive actions (CAPAs) and performs proper follow-up of assigned action plans.
  • Evaluates data for quality system performance tracking and trending.
  • Coordinates the gathering and reporting of metrics.
  • Assists with identification and review of Quality Events/issues, develops solution proposals and decisions with input from QA management.
  • Assists with the preparation of GXO inspection readiness activities
  • Participates in SOP development, review, and approval to maintain compliance to regulations.
  • Reports internal, investigator site and CRO audit metrics to QA compliance management.
  • Supports corporate activities such as, corporate compliance internal audits and assessments, and implementation of quality policies and standards.
  • May deliver predefined training modules to the organization.
  • May provide approval of quality records, as designated by a higher level within the Quality Organization.
  • Works on other projects as assigned.
A minimum of a Bachelor's degree in either a scientific discipline or mathematics is required. Equivalent experience may be accepted. A minimum of 8 years related experience is required. A minimum of 6-8 years' experience in the pharmaceutical industry working in a GXP environment is required. Strong oral and written communication skills are required. A thorough knowledge of FDA regulations and GCPs for drugs is a must.

We are an Equal Opportunity Employer and do not discriminate against applicants due to race, ethnicity, gender, veteran status, or on the basis of disability or any other federal, state or local protected class. Nektar Therapeutics will consider for employment qualified applicants with criminal histories in the manner proscribed by the San Francisco Fair Chance Ordinance.