Specialist I, QA

San Diego, CA, US
Sep 22, 2020
Biotech Beach
Required Education
Bachelors Degree
Position Type
Full time
Those who join Emergent BioSolutions feel a sense of ownership about their future. You will excel in an environment characterized by respect, innovation and growth opportunities. Here, you will join passionate professionals who advance their scientific, technical and professional skills to develop products designed-to protect life.

Position Summary

Specialist I, Quality Assurance position is a quality professional responsible for QA oversight of cGMP manufacturing activities and testing processes. Specialist I, QA is responsible for QA oversight of production/testing processes and the execution of routine Quality System work.

Specialist I, QA will perform batch record review and support batch release related activities. The QA Specialist will interact with in-house and CMO teams to provide guidance necessary to maintain and improve cGMP compliance at the company. This position frequently interacts with area team leads, supervisors, other cross functional peers, and CMOs.

Essential Functions

Reasonable accommodations will be made to enable individuals with disabilities to perform the essential functions.
  • Responsible for QA oversight of cGMP activities related to the manufacturing of early phase development products. Provides cGMP phase appropriate QA oversight for Deviations/Investigations, CAPAs, Batch Record Reviews, Product Release and Change Control initiations, reviews or approvals
  • Maintain relationships with vendors, contractors, and consultants to ensure effective execution of assigned drug development tasks per phase appropriate guidance
  • Critically reviews executed batch records and various types of controlled document in accordance to internal and regulatory requirements. This includes but not limited to SOPs, work instructions, protocols/reports, specifications, and logbooks
  • Coordinate and support the development and execution of change control plans to ensure compliant implementation of product and/or process changes
  • Perform on the Floor support for manufacturing operations such as line clearance, and QA hold for cleanrooms and room release
  • Assist in the investigation and writing of quality events such as deviations, complaints, OOS, and OOT
  • Assist with internal audits in accordance with pre-defined schedule

Quality System Support
  • Author and execute tasks for document revisions, non-conformances, CAPAs, deviations, and change controls
  • Perform gap assessment as needed to support quality harmonization and improvement initiatives

  • Demonstrate initiative and accountability in a fast-paced environment with minimal supervision
  • Strong hands-on knowledge and ability to identify and/or independently resolve moderately complex quality issues with other functions in a proactive, diplomatic, flexible and constructive manner

Minimum Education, Experience and Skills

Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

Bachelor's degree in Biological Science or similar discipline
  • Minimum 5 to 10 years of QC and/or QA experience in cGMP environment
  • Knowledge of 21 CFR 210, 211, 600 requirements
  • Knowledge of qualification and validation of analytical methods
  • Must have strong knowledge of controlled document lifecycle
  • Experience to review cGMP batch records
  • Must have strong attention to detail
  • Ability to manage multiple priorities and tasks in a dynamic environment
  • Excellent written and verbal skills
  • Must exhibit strong interpersonal and communication skills
  • Ability to exercise judgment to determine appropriate corrective/preventative actions
  • Ability to exercise judgment for defined practices and policies in selecting methods and techniques for obtaining solutions
  • Ability to use Microsoft Office suites
  • Experience of using electronic quality management system is preferred
  • Ability to make sound decisions regarding compliance-related issues with moderate supervision
  • Demonstrate strong organization skills related to priorities and workload
  • Ability to solve problems independently and within a team environment

There are physical/mental demands and work environment characteristics that must be met by an individual to successfully perform the essential functions of the job. This information is available upon request from the candidate.

Reasonable accommodations may be made to enable individuals with disabilities to perform all essential functions.

Emergent BioSolutions is an Equal Opportunity/Affirmative Action Employer and values the diversity of our workforce. Emergent does not discriminate on the basis of race, color, creed, religion, sex or gender (including pregnancy, childbirth, and related medical conditions), gender identity or gender expression (including transgender status), sexual orientation, age, national origin, ancestry, citizenship status, marital status, physical or mental disability, military service or veteran status, genetic information or any other characteristics protected by applicable federal, state or local law.

Information submitted will be used by Emergent BioSolutions for activities related to your prospective employment. Emergent BioSolutions respects your privacy and any use of the information submitted will be subject to the terms of our Privacy Policy .

Emergent BioSolutions does not accept non-solicited resumes or candidate submittals from search/recruiting agencies not already on Emergent BioSolutions' approved agency list. Unsolicited resumes or candidate information submitted to Emergent BioSolutions by search/recruiting agencies not already on Emergent BioSolutions' approved agency list shall become the property of Emergent BioSolutions and if the candidate is subsequently hired by Emergent BioSolutions, Emergent BioSolutions shall not owe any fee to the submitting agency.