Analyst III, QC Incoming Inspection

Company: Emergent BioSolutions
Location: Lansing
Posted on: May 16, 2020

Job Description:

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.

JOB SUMMARY

The Analyst III for this position will perform tasks associated with the incoming inspection process including inspecting, testing and evaluating raw materials and packaging components per USP/EP compendial methods and standard test methods. Support program improvements including SOP s, improved specifications, raw material qualification program and alignment of raw material procurement with other Emergent sites. Streamline and improve compliance and efficiency in Quality Control programs and develop, implement and maintain quality control systems and activities. Conduct out-of-specification and failure investigations, recommend and implement corrective actions.



ESSENTIAL FUNCTIONS

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

* Assist with cleaning and maintaining stability chambers and laboratory space (including mopping/wiping with cleaning agents, ensuring proper function, tag out non-functioning equipment, etc.)
* Assist with various QC projects as necessary
* Create new and revise existing SOP s and specifications; write deviations, CAPA s, and Change Controls as needed.
* Perform incoming inspections which includes:

* Following cleanroom behavior and gowning

* Material sampling

* Performing Physical Characteristics Testing

* Perform AQL inspections

* Assist with inventory reconciliation and maintenance of retention and stability samples

* Perform composite preparation

* Perform sample shipping to third party contract laboratories

* Disposition activities for raw materials

* Perform sampling activities to support the stability program.
* Schedule daily activities for routine inspection and testing of raw materials
* Conduct training for the incoming inspection process
* Support raw material testing equipment and instrument qualification, calibration and preventative maintenance as assigned

The above statements are intended to describe the nature of work performed by those in this job and are not an exhaustive list of all duties. Nothing in this job description restricts managements right to assign or reassign duties and responsibilities to this job at any time which reflects management s assignment of essential functions.



MINIMUM EDUCATION, EXPERIENCE, SKILLS
* B.S. Chemistry, Microbiology or other related scientific field
* 3-5 years experience within a cGMP / FDA / Pharmaceutical environment.
* Previous experience working with stability programs/samples is desired but not required.
* Strong written and oral communications skills
* Strong initiative, organization and ability to work independently
* Must have strong computer skills with MS Word, Excel, and Adobe
* Knowledge of LIMS systems



PHYSICAL/MENTAL DEMANDS AND WORK ENVIRONMENT CHARACTERISTICS
The physical/mental demands are representative of those that must be met by an individual to successfully perform the essential functions of the job.

The work environment characteristics described here are representative of those an individual would encounter while performing the essential functions of the job.

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

Physical/Mental Demands and Work Environment Characteristics:

Mental Demands:
Ability to organize/coordinate Comprehend and follow instructions

Direct, control and plan Independently make quick decisions to solve complex issues

Problem Solve Analyze/Interpret data and information

Perform with frequent interruptions Make decisions using sound judgment

Supervise/Manage others

Physical Demands:
Good eye/hand coordination Visual Acuity

Use keyboard/computer/phone Detect/Distinguish smell

Detect/Distinguish hearing Maintain stationary position

Position self to move Move/Traverse

Ascend/Descend (climb) Reaching

Calibrate precise Ability to safely operate hand tools
measurements

Move/Transport 25-50 lb. Repetitive movement activities

Environmental Characteristics:

Regular and predictable attendance

Work around extreme temperatures cold or hot

Work around noise above conversation level

Work in restricted access to laboratory area

Exposure to dust/gas/fumes/steam/chemicals

Work with Select Agents as defined by the CDC

Work irregular hours that often include nights and weekends

Work in multiple locations

Travel:

No travel required.

Emergent BioSolutions is an Equal Opportunity/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, gender, age, national origin, disability, Protected Veteran status, sexual orientation, or any other characteristic protected by 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.

Keywords: Emergent BioSolutions, Lansing , Analyst III, QC Incoming Inspection, Professions , Lansing, Michigan