Analyst III, QC Analytical

We go where others won't, taking on some of the biggest public health challenges to protect and enhance millions of lives, and create a better, more secure world. Here, you will join passionate professionals who advance their scientific, technical and professional skills to develop products designed-to protect and enhance life.

I: Job Summary

This position will be responsible for providing testing and scheduling support to QC Analytical/ Lot Release group to ensure all finished goods, in-process samples, MTech samples and stability samples are tested and released on time to meet business needs and cGMP requirements. This position will also be responsible for writing deviations, CAPAs, change controls and lab investigations as needed. Support equipment and assay qualifications as required. Provide training to QC Release group analysts and represent the QC department in meetings as assigned.

II: Responsibilites

Testing and Review

• Performs testing proficiency in at least two areas of laboratory testing such as:
  • HPLC
  • ELISA
  • Cell culture
  • Plaque based potency assay
  • KF titrations
• Protocol-driven non-routine testing
• Peer review (calculations, logs, etc.)
• Support equipment qualifications
• Support method development activities

Quality Control Systems:

• Understanding of compliance/guidance/regulations pertaining to assigned area
• Identifies and supports change and continuous improvement using LEAN practices such as 5S and Kaizen
• Author laboratory investigations and revise Standard Operating Procedures through independent thought and collaboration with minimal Supervisor support
• Author and manage CAPAs and Change controls as they relate to the position

Laboratory Support:

• Sample Log In and traceability
• Monitor controlled temperature units
• Receive, label, and restock reagents and supplies
• Laboratory upkeep/housekeeping activities

Behavioral/Cultural Responsibilities:

• Ownership- actively participate in self-development (SLII, IPMP)
• Accountability- follow through on commitments
• Detail oriented- able to complete required tasks and associated documentation with minimal error
• Adaptability- maintain positive attitude in a changing work environment
• Communication- effectively communicate with all levels of staff
• Actively participate in department/level meetings
• Escalate issues through the proper channels

The above statements are intended to describe the general nature of work performed by those in this job. It is not an exhaustive list of all duties, and other duties may be assigned.

III: Education, Experience & Skills

• Bachelors or Master's Degree in a scientific discipline
• Minimum of 8 years of related experience
• Hands-on experience with one or more assays and instruments: cell-based potency assays, cell culture, ELISA, HPLC, KF titrations, and physical inspection/appearance.
• Must have SOP, investigation, and project protocol writing skills
• Strong technical and communication skills: oral/written and listening
• Must have an understanding of cGMPs, CFR, USP, and Aseptic Processing Guidelines
• Personal Competencies: Self-awareness, Integrity, Team Player, Creative, and Flexible.
• Computer skills (MS Office, JMP statistical software, Visio, MS Project)

Per CDC guidelines, Emergent strongly recommends that all employees working on site are vaccinated to help ensure their safety, as well as the safety of fellow employees. This includes the use of good judgment when determining when the CDC guidelines advise that you stay home when ill.

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.

ABOUT EMERGENT

Protecting and Enhancing 1 billion lives by 2030 focuses our energy to improve the quality of life for individuals around the world, giving them the opportunity to experience the fullness of life.

Our drive towards this vision informs all of our actions-whether it is our approach to product development, manufacturing, encouraging employee health and wellness or giving back to the community-we strive every day to achieve this shared goal.

WE BELIEVE IN OUR VALUES

• Lead with Integrity
  • We gain trust and confidence through ethics, quality, and compliance excellence
• Stand shoulder to shoulder no matter what
  • We combine our best thinking and communicate openly to support each other.
• Own it always
  • Every person at Emergent is engaged and accountable for delivering on our commitments.
• Break through thinking
  • We take smart risks, pursue innovation and challenge ourselves to constantly improve.
• Compete where it counts
  • We set the right goals and respect each other as we conquer them together.