Specialist I, Quality Assurance

Location
San Diego, CA, US
Posted
May 27, 2021
Ref
727189600
Hotbed
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 activities of cGMP manufacturing, CMOs, compliance, supplier management, internal/external audits, and the execution of routine quality system work as needed.

The QA Specialist I will interact with in-house and CMO teams to provide necessary guidance 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 and testing of early phase development products. Provides cGMP phase appropriate QA oversight for Analytical Data Reviews, Deviations/Investigations, CAPAs, Batch Record Reviews, Product Release and Change Control initiations, reviews, or approvals.
  • Review controlled documents in accordance with internal procedures and regulatory requirements. This includes but not limited to SOPs, work instructions, protocols/reports, specifications, and logbooks.
  • Assist in the investigation and review of reports related to deviations, OOS, and OOT, CAPAs, and Change Control requests.
  • Coordinate and support the development and execution of change control plans to ensure compliant implementation of product, process, material, equipment, and/or system changes.
  • Maintain relationships with vendors, contractors, and consultants to ensure effective execution of assigned drug development tasks per phase appropriate guidance.

Quality System
  • Experience with non-conformances, CAPAs, deviations, and change controls.
  • Contribute to the harmonization and improvement initiatives of the business (e.g. performing gap assessments, lead the implementation efforts)
  • Contribute to global project of Data Integrity

Management/Competencies
  • 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
  • Bachelor's degree in Biological Science, Chemistry, or similar discipline
  • 5-10 years of QC and/or QA experience in cGMP environment
  • Knowledge of 21 CFR 210, 211, 600 requirements
  • Knowledge of pharmaceutical quality systems
  • Experience of conducting internal, external, and regulatory audits
  • Experience working with biologics and early phase developmental projects
  • Must have experience working with controlled documents
  • 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 use business practices and policies to resolve any difficult situations independently
  • Ability to use Microsoft Word, Excel, Power Point
  • Experienced in electronic systems (Veeva, SAP, LIMS, etc.)
  • Decision making ability on compliance-related issues with minimal supervision


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.

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