QC Biochemist

The Fountain Group; Maryland; On-site; USD 28,000 - 41,000; Full time

Job summary

The Fountain Group is seeking a QC Biochemist for a 6-month contract in Frederick, MD, with a pay rate of $20-$30 per hour. For the first seven weeks, onboarding runs Mon-Fri 7:30am-4pm; after that, the shift is Wed-Sat 3PM–1:30AM EST.

Responsibilities include testing of raw materials and products by cell-based bioassays, flow cytometry, ELISA and qPCR; maintaining equipment; and preparing CoAs for product release while ensuring GMP compliance.

Qualifications

• Bachelor's Degree or AA with 2+ years' biotech/QC experience or High School + 3+ years biotech/QC experience.
• GMP knowledge and experience with SOPs and QC processes.
• Proficient with MS Word, Excel, PowerPoint and related software.

Responsibilities

• Perform testing of raw materials, intermediates and finished products using cell-based bioassays, flow cytometry, ELISA and qPCR.
• Maintain and calibrate laboratory instruments; assist with SOPs, qualification/validation protocols and reports.
• Review data for in-process testing, drug substance and drug product release; generate CoAs.
• Participate in investigations of OOS results and root-cause analysis; communicate findings in meetings.
• Ensure GMP systems are followed and support regulatory submissions as needed.

Skills

GMP knowledge

Quality control

Strong communication

Lab techniques

Education

Bachelor's Degree

AA Degree + 2+ years QC

High School Diploma + 3+ years QC

Tools

MS Word

Excel

PowerPoint

Job description

Currently we have an opening for a QC Biochemist located in Frederick, MD. Details for the positionare as follows:

Pay Range

$20-$30/hour

Job Description

• 6-month contract with the possibility of extending or converting to permanent based on performance and budget.
• For the first 7 weeks of the assignment, all contractors are required to work Mon-Fri 7:30am-4pm to complete New Hire Orientation and Manufacturing On-boarding Technical Training. After the 7 weeks, the contractor is deployed onto their agreed upon shift.
• Shift: Wed-Saturday - 3PM - 1:30AM EST
• 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

• Bachelor's 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 OOS's 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.