Quality Control Chemist I

Planet Pharma; Frederick (MD); On-site; USD 34,000 - 41,000; Full time

Job summary

Planet Pharma in Frederick, MD is seeking a Quality Control Technician to perform testing of raw materials, intermediates and final products using Cell-based bioassays, Flow Cytometry, ELISA and qPCR. You will support data trending, generate CoAs, and maintain instrument calibration.

Required: degree with biotech/QA experience or related field; GMP knowledge; proficiency in MS Word/Excel/PowerPoint; strong communication; ability to work independently. Pay range 25–30 USD/hr.

Qualifications

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

Responsibilities

• Perform testing of raw materials, intermediates and final products by analytical methods including Cell-based bioassays, Flow Cytometry, ELISA and qPCR.
• Maintain lab in an optimal state with internal and external resources.
• Assist with monitoring and trending data and prepare CoAs for product release.

Skills

GMP knowledge

MS Word

MS Excel

PowerPoint

Written communication

Independent work

Data trending

CoA generation

Education

Bachelor's degree

AA degree + 2+ years QA

High School + 3+ years QA

Tools

Flow Cytometry

ELISA

qPCR

Job description

Responsibilities (include but are not limited to):

• Perform testing of raw materials, intermediates and final products by following analytical methods: Cell based bioassays, Flow Cytometry, ELISA and qPCR assays.
• Work with internal and external resources to maintain lab in an optimal state.
• 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. Supply information to support generation of CoAs for product release.
• Maintains laboratory instruments for calibration and routine maintenance
• Author or revise SOPs, qualification/validation protocols and reports.
• Asist with lab investigations regarding out of specifications (OOS) results. Participate in determination of root cause for deviations related to analytical procedures.
• Provide updates at daily and weekly meetings.
• Monitor the GMP systems currently in place to ensure compliance with documented policies.
• Gather metric information for use in continuous improvement of areas of responsibility.
• Perform other duties as required.

Review proposed changes to systems, procedures, methods, and submissions to regulatory agencies, as appropriate.

Basic Qualifications:

• Bachelors Degree OR
• AA Degree and 2+ years experience in biotechnology or related field and Quality Control experience OR
• High School Degree and 3+ years experience in biotechnology or related field and Quality Control experience

Preferred Qualifications:

• Strong knowledge of GMP, SOPs and quality control processes.
• Identifying, writing, evaluating, and closing OOSs and investigations.
• Proficient in MS Word, Excel, Power Point and other applications.
• Strong written and verbal communication skills.
• Ability to communicate and work independently with scientific/technical personnel.
• Well versed in various analytical techniques such as Flow Cytometry, ELISAs, PCR, and cell bioassays and other applicable methods to the testing of biopharmaceuticals.
• Working knowledge of quality systems and regulatory requirements (21 CRF Part 11/210/211).
• Preferred: Experience in the biotech and/or pharmaceutical industry

Pay ranges between 25-30/hr based on experience