Quality Control analyst II

ABOUT NOVEOME BIOTHERAPEUTICS, INC.

Noveome Biotherapeutics, Inc. is a dynamic biopharmaceutical company with an innovative platform technology that represents a paradigm shift in drug development. Unlike most drugs that are single molecules directed at specific indications, Noveome’s product is a complex mixture of biomolecules that is believed to have the ability to treat a wide range of conditions and injuries. Noveome collaborates with major research centers to advance these therapeutic applications.

POSITION OBJECTIVE

The Quality Control Analyst II is responsible for conducting routine chemical and biological testing of raw materials, intermediates, finished products, and stability samples. This position works independently while following defined standard operating procedures. This position also documents the testing process, performs an initial review of testing results and identifies trends. The Quality Control Analyst II will maintain data integrity and ensure compliance with laboratory safety procedures.

WHAT YOU WILL DO FOR NOVEOME

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

· Follows standard operating procedures while performing laboratory testing of raw materials, intermediate product, finished product, and stability samples.

· Provides lab support including ordering of materials, reagent preparation, general laboratory cleaning, and routine equipment maintenance.

· Compiles laboratory data regarding compliance with specifications and reports abnormalities, deviations, or out-of-specifications to management. Assists in the evaluation of these operational issues.

· Assists in routine troubleshooting of assay and instrument problems.

· Performs analytical method validation activities and equipment qualifications.

· Completes documentation needed to support testing procedures, including equipment logs, lab notebooks, or inventory forms.

· Provides data for department meetings regarding trend analysis and makes observations in support of investigations.

· Assists in the periodic review and revision of standard operating procedures and drafts new ones as needed.

· Assists with special projects relating to stability, raw materials management, environmental monitoring, analytical and instrument problem solving, or process improvement.

· Assists in training new QC Analysts on routine procedures and practices.

· Ensures laboratory safety standards are maintained.

Please note, as a company rooted in innovation, our positions are consistently evolving and we champion the development of all roles. This job description is not designed to contain comprehensive listing of all responsibilities that are required, as they may change to meet the ongoing needs of the Company.

REQUIRED QUALIFICATIONS

· Documentation protocols

· Laboratory mathematics skills

· Micro-volume pipetting techniques

· Cell culture methods

· Laboratory instrumentation – spectrophotometers, analytical balances, pH meters

· Advanced knowledge of cGMP regulations

· Basic chemical and biological safety procedures

BENEFICIAL QUALIFICATIONS

· Microbiological techniques such as streaking and plating

· Electrophoresis

· ELISA and other bioassays

· PCR and other molecular biology methods

· Experience with Change Controls and writing of investigations/deviations

ATTRIBUTES OF SUCCESS

Reliability Time Management Detail Oriented

Goal Oriented Continuous Learning Integrity

WORK ENVIRONMENT/PHYSICAL DEMANDS

Requires a combination of sedentary work and standing for extended periods of time in the Quality Control labs where personal protective equipment is required. Duties require fine finger dexterity, writing, typing, hearing, reading, and depth perception.

REGULAR SCHEDULE

This is an hourly full-time position with a regular schedule of Monday through Friday work hours. Extended hours may be needed on occasion to complete company objectives. This position requires the incumbent to be physically present onsite.

WHAT NOVEOME WILL DO FOR YOU

Noveome provides transparency in expectations, encourages innovative thinking, opportunities for expanded learning, competitive salaries, and a clean safe work environment. Eligible employees will appreciate the comprehensive benefits package and wellness perks.

LOCATION PITTSBURGH

REPORTS TO SENIOR QUALITY CONTROL MANAGER

MANAGES OTHERS NO

EDUCATION/YEARS’ EXPERIENCE BACHELOR’S DEGREE IN A BIOLOGOCAL SCIENCE WITH 3+ YEARS’ EXPERIENCE OR MASTER’S DEGREE IN A BIOLOGICAL SCIENCE WITH 1+ YEARS’ EXPERIENCE 1+ YEARS’ EXPERIENCE SHOULD BE IN A GMP QC ENVIRONMENT

RELATED DEGREE PROGRAMS CHEMISTRY, BIOCHEMISTRY, BIOLOGY, MICROBIOLOGY

A combination of experience and/or education will be taken into consideration.

Noveome is an Equal Opportunity Employer.