Quality Control Chemist I

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

Job summary

Planet Pharma seeks a Biotechnology QA/Analytical Technician to perform testing of materials and products using cell-based assays, Flow Cytometry, ELISA and qPCR. You will support data trending, CoA generation, and maintain calibration of instruments.

The role requires GMP knowledge, SOP familiarity, and effective communication in a collaborative biotech environment. On-site position in Frederick, MD with opportunities to contribute to continuous quality improvements.

Qualifications

• Bachelor's degree required; alternative AA with 2+ years in biotech/QA
• High School with 3+ years in biotech/QA acceptable
• Strong GMP/SOP knowledge and QC processes required

Responsibilities

• Test raw materials, intermediates and final products using cell-based bioassays, flow cytometry, ELISA and qPCR.
• Maintain lab equipment; prepare CoAs for product release.
• Review data and documents for in-process testing and release; support investigations of OOS results.
• Update GMP systems and participate in daily/weekly meetings; ensure policy compliance.
• Draft/revise SOPs and validation/qualification protocols.

Skills

GMP knowledge

Quality control

OOS investigations

Written & verbal communication

MS Office

Flow Cytometry

ELISA

PCR

Cell bioassays

Education

Bachelor's Degree

AA Degree + 2+ years QC

HS Diploma + 3+ years QA

Tools

MS Word

Excel

PowerPoint

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.

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

• Gather metric information for use in continuous improvement of areas of responsibility.
• Perform other duties as required.

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