Job Title: QC Analyst II, Environmental Monitoring

Job Description

The QC Analyst, EM position will require performing environmental monitoring sampling and incubation, and analyzing and reporting data according to quality requirements to support GMP manufacturing. Secondary responsibilities include GMP lot release testing.

Responsibilities

• Perform environmental monitoring duties including sampling of viable surfaces, viable air, and non-viable particulates in a GMP Manufacturing Facility.
• Incubate and culture viable EM samples.
• Perform GMP personnel gowning certifications.
• Report results from environmental monitoring and personnel samples and ship for ID testing, when applicable.
• Report and investigate environmental monitoring excursions.
• Track and trend EM data.
• Write and revise QC procedures related to environmental monitoring procedures and equipment.
• Perform QC testing of raw materials and schedule testing through contract testing laboratories.
• Perform QC lot release testing including, but not limited to: Endotoxin, Gram Stain.
• Maintain and operate QC laboratory equipment in a cGMP-compliant manner.
• Perform general laboratory maintenance, including ordering and receiving QC materials.

Essential Skills

• Bachelor’s Degree in Biological Science or related discipline.
• Minimum of 2-years environmental monitoring experience in a GMP environment.
• Knowledge in principles and practices of current Good Manufacturing Practices (cGMPs).
• Experience with methods and systems used in a biological QC environment.
• Proficient in MS-Word and MS-Excel.
• Strong quantitative and analytical skills.

Additional Skills & Qualifications

• Comfortable in a fast-paced company environment and able to adjust workload based upon changing priorities.
• Self-motivated and willing to accept responsibilities outside of initial job description and perform other responsibilities to support the needs of the department, as assigned.
• Positive interpersonal skills.
• Self-organizer, meticulous hands-on habits, keen attention to detail.
• Ability to manage multiple and varied tasks, and prioritize workload.
• Excellent interpersonal, verbal and written communication skills are essential in this collaborative work environment.
• Ability to understand and execute on the company’s mission and values.
• Maintain a high degree of ethical standard and trustworthiness.
• Responsive, can-do attitude.
• Deals with conflict in a direct, positive manner.
• Ability to think and adapt to a rapidly changing environment and demands.

Work Environment

Office/GMP Suite.

Pay and Benefits

The pay range for this position is $68000.00 - $80000.00/yr.

Paid time off, Holiday pay, Medical, Dental, Vision, 401K participation and company match. Will request current benefits overview.

Workplace Type

This is a fully onsite position in Germantown,MD.

Application Deadline

This position is anticipated to close on Feb 21, 2025.

About Actalent

Actalent is a global leader in engineering and sciences services and talent solutions. We help visionary companies advance their engineering and science initiatives through access to specialized experts who drive scale, innovation and speed to market. With a network of almost 30,000 consultants and more than 4,500 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500.

Diversity, Equity & Inclusion

At Actalent, diversity and inclusion are a bridge towards the equity and success of our people. DE&I are embedded into our culture through:

• Hiring diverse talent
• Maintaining an inclusive environment through persistent self-reflection
• Building a culture of care, engagement, and recognition with clear outcomes
• Ensuring growth opportunities for our people

The company is an equal opportunity employer and will consider all applications without regard to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.

If you would like to request a reasonable accommodation, such as the modification or adjustment of the job application process or interviewing process due to a disability, please email actalentaccommodation@actalentservices.com for other accommodation options.

Salary : $68,000 - $80,000