QC Analyst I/II - Environmental Monitoring

Description

MacroGenics is a leader in the discovery and development of innovative medicines that utilize our next generation antibody-based technologies. Our team of 300+ dedicated individuals is advancing a pipeline of product candidates to treat patients with cancer as well as various autoimmune disorders and infectious diseases. Our products and platforms have attracted multiple partnerships with leading pharmaceutical companies around the globe.

The Company considers its employees to be its most valuable asset and we are committed to providing opportunities for individuals to learn and grow as a means to further their professional development. MacroGenics' corporate culture promotes an atmosphere of innovation, open communication and teamwork where employees can see firsthand how they contribute to the success of the organization.

Summary of Position

This position is responsible for performing activities in support of the microbiology and environmental monitoring testing programs including monitoring of the manufacturing cleanrooms. This individual will be required to complete the testing and related documentation in a timely manner while adhering to standard operating procedures and under cGMPs.

Responsibilities and Job Duties:

QC Analyst I

• Collects routine environmental monitoring (EM) samples and water samples and performs plate enumeration on a daily basis in accordance with all protocols and procedures.
• Performs basic water testing such as pH and conductivity in accordance with standard operating procedures.
• Enters sampling and testing data into laboratory data system, and ensure adherence to standard operating procedures and cGMPs.
• Performs routine lab cleaning and equipment maintenance activities in accordance with SOPS as scheduled, and escalates potential equipment issues to supervisor.
• Reports out of specification results from the sampling and testing to supervisor and assists with performing laboratory investigations to determine the root cause and possible resolution.
• Revises and updates standard operating procedures, as assigned with guidance from senior analysts and/or supervisor.

QC Analyst II

• Collects routine environmental monitoring (EM) samples and water samples on a daily basis in accordance with all protocols and procedures.
• Conducts microbiology testing such as Bioburden, Endotoxin, and TOC for raw materials, in-process, and final formulation samples in accordance with standard operating procedures.
• Conducts plate enumeration and microbial identification as needed.
• Enters and reviews data into laboratory data system to ensure data integrity and adherence to standard operating procedures and GMPs.
• Ensures lab equipment is calibrated and maintained as required for testing per standard operating procedures.
• Reports "out of specification" results from sampling and testing to supervisor and assists with performing laboratory investigations.
• Revises and updates standard operating procedures, as needed.
• May perform special projects related to problems encountered with microbial testing and instruments and make recommendations for solutions that will minimize future issues.

Qualifications

Education, Experience, & Credentials

QC Analyst I

• High School Diploma and minimum of one year experience in performing Environmental Monitoring and Microbiology testing.
• Bachelor's Degree in a scientific discipline

QC Analyst II

• High School Diploma and minimum of three years of experience in performing Environmental Monitoring and Microbiology testing.
• Associate's degree in a scientific area of study with two years of related experience;
• Bachelor's Degree in a scientific discipline and minimum of two years' related experience
• Experience in one or more of the following areas required: Environmental Monitoring, Quality Control, Microbiology, and/or GMP production.

Knowledge, Skills and Abilities

• Working knowledge of good in performing Environmental Monitoring or Microbiology testing.
• Needs to be able to follow directions that are outlined in SOPs and other quality guidelines.
• Ability to organize daily activities to meet internal customer needs in a fast-paced environment
• Ability to understand when he/she should seek advice and guidance
• Data entry skills
• Be able to work in a team environment in a cooperative and respectful manner.
• Ability to stand for periods of time when performing tasks on the floor.
• Ability to work a varied schedule including off shift and weekends.
• Ability to lift up to 50 pounds.

Supervisory Responsibilities

None

Additional Information

The annual rate of pay for this position ranges from $52,600 to $79,100 (Quality Control Analyst I) and $68,400 to $102,700 (Quality Control Analyst II). For non-exempt roles, and according to applicable regulations, there may be the possibility for overtime pay. This role is eligible for the Company's discretionary bonus and discretionary equity incentives. Eligible employees may participate in the Company's benefits programs, including medical / dental / vision / prescription coverage, employee wellness resources, 401(k) plan with employer match, access to an Employee Stock Purchase Plan, (ESPP), paid time off & paid parental leave benefits, and disability benefits.

The annual pay rate range is described in good faith, and the Company believes is the range of possible compensation for this role at the time of this posting depending on the candidate's experience, qualifications, geographic location, and other factors permitted by law. The Company may ultimately pay more or less than the posted range, and this range may be modified in the future. No amount is considered to be wages or compensation until such amount is earned, vested, and determinable under the terms and conditions of the applicable policies and plans. The amount and availability of any bonus, commission, benefits, or any other form of compensation and benefits that are allocable to a particular employee remains in the Company's sole discretion unless and until paid and may be modified at the Company's sole discretion, consistent with the law.

Statement

MacroGenics is proud to be an equal opportunity employer. Employment selection and related decisions are made without regard to race, color, national origin, sex, gender identity, sexual orientation, religion, age, disability, protected veteran status, or any other characteristic protected by federal, state or local law. We are committed to working with and providing reasonable accommodation to individuals with disabilities. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the employment process, please email info@macrogenics.com or call (301) 354-3566 and/or 711 for TTD/TTY service.

Equal Opportunity Employer/Veterans/Disabled