Quality Control Chemist - I*

Mindlance; Frederick (MD); On-site; USD 50,000 - 80,000; Full time

Job summary

An established industry player is seeking a Quality Control Chemist to join their dynamic team in Frederick. This role involves performing critical testing of raw materials and final products, ensuring compliance with GMP standards, and maintaining laboratory instruments. The ideal candidate will have a strong background in biotechnology, solid analytical skills, and the ability to work independently. This position offers a unique opportunity to contribute to the quality assurance processes in a fast-paced environment, making a significant impact on product integrity and safety. If you are passionate about quality control and eager to work in a collaborative setting, this role is perfect for you.

Qualifications

• Bachelor’s degree in a related field or equivalent experience required.
• Strong knowledge of GMP and quality control processes is essential.

Responsibilities

• Perform testing of raw materials and final products using various analytical methods.
• Maintain laboratory instruments and ensure compliance with GMP systems.

Skills

GMP knowledge

Quality Control processes

Analytical techniques (Flow Cytometry, ELISA, qPCR)

Written and verbal communication

Data monitoring and trending

Education

Bachelor’s Degree

AA Degree with 2+ years’ experience

High School Degree with 3+ years’ experience

Tools

MS Word

MS Excel

MS PowerPoint

Job description

Job Title - Quality Control Chemist
Location - Frederick, MD
Onsite - Shift flexibility preferred

Shift is Wed-Sat 07:00 - 17:30

IMPORTANT: For the first 7 weeks of the assignment, all contractors are required to work Mon-Fri (07:30-16:00) to complete New Hire Orientation and Manufacturing Onboarding Technical Training. After the 7 weeks, the contractor is deployed onto their agreed upon shift. New hires will need to complete this training.

Responsibilities (include but are not limited to):

1. Perform testing of raw materials, intermediates, and final products by following analytical methods: Cell-based bioassays, Flow Cytometry, ELISA, and qPCR assays.
2. Work with internal and external resources to maintain the lab in an optimal state.
3. Assist with monitoring and trending data, complete routine record review of test data and related documents for in-process testing, drug substance, and drug product release. Provide information to support generation of CoAs for product release.
4. Maintain laboratory instruments for calibration and routine maintenance.
5. Author or revise SOPs, qualification/validation protocols, and reports.
6. Assist with lab investigations regarding out-of-specifications (OOS) results. Participate in root cause analysis for deviations related to analytical procedures.
7. Provide updates at daily and weekly meetings.
8. Monitor GMP systems to ensure compliance with documented policies.
9. Review proposed changes to systems, procedures, methods, and submissions to regulatory agencies as appropriate.
10. Gather metrics for continuous improvement of areas of responsibility.
11. Perform other duties as required.

Basic Qualifications:

1. Bachelor’s Degree OR
2. AA Degree with 2+ years’ experience in biotechnology or related field and Quality Control experience OR
3. High School Degree with 3+ years’ experience in biotechnology or related field and Quality Control experience

Preferred Qualifications:

1. Strong knowledge of GMP, SOPs, and quality control processes.
2. Experience in identifying, writing, evaluating, and closing OOS investigations.
3. Proficient in MS Word, Excel, PowerPoint, and other applications.
4. Strong written and verbal communication skills.
5. Ability to work independently with scientific/technical personnel.
6. Well-versed in analytical techniques such as Flow Cytometry, ELISAs, PCR, and cell bioassays.
7. Knowledge of quality systems and regulatory requirements (21 CFR Part 11/210/211).
8. Preferred: Experience in the biotech and/or pharmaceutical industry.

EEO:

Mindlance is an Equal Opportunity Employer and does not discriminate based on Minority, Gender, Disability, Religion, LGBTQI, Age, or Veterans status.