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