Analyst I, QC Chemistry - Limited Term

 

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.

JOB SUMMARY 

This is a laboratory testing position with the major responsibilities of daily routine product release testing and laboratory maintenance tasks. Additional responsibilities involve quality systems support. This position will require weekend work.

 

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

 

Testing and Technical Expertise:
•    Demonstrates a basic understanding of compliance, guidance, and regulations (ISO, USP, FDA, EU) pertaining to assigned area.
•    Performs routine testing following written procedures and limited non-routine testing including validation studies with supervisory oversight.
•    Performs testing competently in at least one area of chemistry testing techniques such as, but not limited to:

• Serum testing (ELISA, Bradford, SDS-PAGE, BCA)
• Gel Electrophoresis (SDS-PAGE, Western Blot)
• Analytical Chemistry (Flame AA, UV-Vis/spectrophotometry)
• Wet Chemistry (pH, Sodium Chloride)

•    Performs testing competently to support environmental monitoring of water testing (conductivity, TOC, nitrates).
Laboratory Support:
•    Conducts peer review (second-person check of QC data).
•    Uses the Laboratory Information Management System (LIMS) for data entry, sample collection, and testing.
•    Demonstrates proficiency in the use and maintenance of standard laboratory equipment.
•    Initiates work notifications.
•    Works with facilities/metrology to conduct and document execution of work orders to ensure GMP compliant state of labs and equipment.
•    Receives, labels, and restocks reagents and supplies.
•    Maintains the lab and associated areas using the LEAN 6S concept.

Quality Systems Support:
•    Provides input to revisions of test methods, standard operating procedures, and work instructions.
•    Supports laboratory investigation, Deviation, CAPA, and Change Control activities.
Continuous Improvement:
•    Participates and supports change and continuous improvement using LEAN practices such as 6S and Kaizen.
•    Coordinates and leads simple improvement initiatives.
Regulatory Inspections:
•    Maintains an audit-ready and pharmaceutically elegant laboratory space.
•    Provides basic support for internal and external audit activities.
Problem Solving:
•    Works on problems of simple to moderate scope in which analysis of situation or data requires a review of identifiable factors.
•    Exercises judgement within defined procedures and practices to determine appropriate action.
•    Follows good laboratory practices and procedures in analyzing situations or data from which answers can be readily obtained.
•    Receives general instructions on routine work, detailed instructions on new assignments.
Behavior/Cultural Responsibilities:
•    Ownership – Actively participate in self-development
•    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 communicates with all levels of manufacturing and support staff
•    Actively participate in department level meetings
•    Escalate issues through the proper channels
•    Demonstrates and upholds Emergent’s Core Values

 

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 management’s 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
•    Bachelor's degree in Chemistry or another closely related field, or equivalent experience.
•    0-2 years experience preferred, or equivalent level of skill and experience.
•    Previous experience with chemistry assays in a GMP manufacturing environment is preferred.
•    Personal Competencies: self-awareness, integrity, team player, innovative, and flexible.
•    An understanding of cGMP, CFR, and USP is preferred.
•    Computer skills in Microsoft Office applications or comparable word-processing and spreadsheet applications is required.

 

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