Quality Control analyst II

Noveome Biotherapeutics, Inc.; Pittsburgh (Allegheny County); On-site; USD 70,000 - 99,000; Full time

Benefits offered by this job

Comprehensive benefits package

Wellness perks

Opportunities for expanded learning

Job summary

Noveome Biotherapeutics, Inc. is seeking a Quality Control Analyst II to conduct routine testing and ensure compliance with safety procedures. This role involves independent work, data integrity maintenance, and collaboration on special projects in a dynamic biopharmaceutical environment. Candidates should possess relevant laboratory skills and a degree in a scientific field.

Qualifications

• Experience with laboratory mathematics and pipetting techniques.
• Knowledge of cGMP regulations and laboratory safety procedures.
• Degree in relevant scientific field.

Responsibilities

• Conduct routine chemical and biological testing of materials.
• Document testing processes and identify trends.
• Assist in training new QC Analysts.

Skills

Laboratory mathematics skills

Micro-volume pipetting techniques

Cell culture methods

Laboratory instrumentation

Advanced knowledge of cGMP regulations

Basic chemical and biological safety procedures

Education

Degree in Chemistry, Biochemistry, Biology, or Microbiology

Tools

Spectrophotometers

Analytical balances

pH meters

Job description

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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 andequipment 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

·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

ReliabilityTime ManagementDetail Oriented

Goal Oriented Continuous LearningIntegrity

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.

LOCATIONPITTSBURGH

REPORTS TOSENIOR QUALITY CONTROL MANAGER

MANAGES OTHERS NO

RELATED DEGREE PROGRAMSCHEMISTRY, BIOCHEMISTRY, BIOLOGY, MICROBIOLOGY

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

Noveome is an Equal Opportunity Employer.

Seniority level

• Seniority level

  Entry level

Employment type

• Employment type

  Full-time

Job function

• Job function

  Quality Assurance

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