Analyst II, QA

Location
San Diego, CA, US
Posted
Oct 09, 2020
Ref
682013300
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

Analyst II is responsible for independent review and release of all GMP raw material, review and oversight of GMP equipment and facility building monitoring system reports. Provide oversight and support of document and records management using company procedures and regulations. Serve as a full Veeva Vault system administrator. Analyze business processes and recommend best practices. Provide support during external audits and regulatory inspections.

Support the Document Control function ensuring controlled documents are created, maintained, and retired according to Emergent Standards. Additionally, collaborates with multiple departments to ensure that GxP records are accessible, retained and available on project or inspection-based requests.

Essential Functions

Reasonable accommodations will be made to enable individuals with disabilities to perform the essential functions.
  • Responsible for Quality oversight of cGMP activities related to the manufacturing of early phase development products.
  • Independently perform quality review and release of raw materials and consumables.
  • Perform review of equipment calibration and preventative maintenance documentation.
  • Perform review of equipment validation documentation.
  • Serve as the primary QA approver of new raw materials added into the inventory management system.
  • Perform issuance of GMP logbooks, review and archiving of controlled documents.
  • Serves as an independent Quality Assurance lead to assigned projects from initiation through targeted completion
  • Support external audits as required
  • Challenge current procedures and practices to afford optimization and further development of existing quality standards and overall compliance.
  • Represent Quality Assurance and Emergent during FDA and other regulatory agency inspections.


Management/Competencies
  • Demonstrate initiative and accountability in a fast-paced environment with minimal supervision on multiple projects
  • 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
  • Identify opportunities for continuous improvement in compliance, business, and safety practices; then plan and implement improvements as applicable.


Minimum Education, Experience and Skills
  • Bachelor Degree in Biological Science or similar science
  • Minimum of 3 to 5 years of pharmaceutical cGMP Quality experience
  • Preferred competence in cGMPs, 21CFR210, 211, 600
  • Must have SOP writing skills and demonstrated ability to critically evaluate content and criticality of information.
  • Must have good written and verbal communication skills. The ability to tailor communications to all levels in the organization and prepare appropriate updates to functional groups.
  • Experience in vaccines development and manufacturing is a plus.
  • Proficiency in MS Office products or comparable word-processing and spreadsheet skills are required.

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.