Quality Control Chemist

SPECTRAFORCE

Frederick (MD)

On-site

USD 60,000 - 68,000

Full time

14 days+

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Job summary

A leading biotechnology firm is seeking a Quality Control Analyst to perform laboratory testing of raw materials and products. The role requires a Bachelor’s degree or equivalent experience in biotechnology, with strong knowledge of GMP standards and analytical techniques. This position offers a flexible on-site schedule and emphasizes compliance with quality systems in a collaborative lab environment.

Qualifications

Bachelor’s Degree or relevant experience in biotechnology or related field.
Experience in Quality Control.
Strong communication and analytical skills.

Responsibilities

Perform testing of raw materials and products.
Maintain laboratory instruments for calibration.
Author or revise SOPs and protocols.

Skills

GMP knowledge

Analytical techniques

Communication skills

MS Office proficiency

Education

Bachelor’s Degree

AA Degree with 2+ years experience

High School Degree with 3+ years experience

Tools

Flow Cytometry

ELISA

qPCR

Job description

1 day ago Be among the first 25 applicants

Direct message the job poster from SPECTRAFORCE

Work Schedule: Wed-Sat 0700-0530

This position's starting pay is: $26.00/hr.

IMPORTANT: For the first 7 weeks of the assignment, all contractors are required to work Mon-Fri (0730-1600) to complete New Hire Orientation and Manufacturing On-boarding Technical Training. After the 7 weeks, the contractor is deployed onto their agreed upon shift. New hires will need to complete

Work Arrangement: Onsite - Shift flexibility preferred

Position Summary:

Perform testing of raw materials, intermediates and final products by following analytical methods: Cell based bioassays, Flow Cytometry, ELISA and qPCR assays.

Key Responsibilities:

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.

Qualifications & Experience:

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.
I am 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.
For information on benefits, equal opportunity employment, and location-specific applicant notices, click here

At SPECTRAFORCE, we are committed to maintaining a workplace that ensures fair compensation and wage transparency in adherence with all applicable state and local laws.

Seniority level