Highlights

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

Description

Our client, a Biopharmaceutical company, is looking for a Quality Control Chemist for their Frederick, MD location.

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.

Requirements:

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
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).
Experience in the biotech and/or pharmaceutical industry

Why Should You Apply?

Health Benefits
Referral Program
Excellent growth and advancement opportunities

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About Company

ICONMA is a global information consulting management firm providing Professional Staffing Services and Project-Based Solutions for organizations in a broad range of industries.

Corporate Headquarters in Troy, Michigan; 20+ locations worldwide.
Certified Woman-Owned Business Enterprise (WBE); certified by Women’s Business Enterprise National Council, National Women Business Owners Corporation (NWBOC); and California Public Utilities Commission (CPUC).
Founded in 2000
2000+ Employees

The company was founded on the principle that success is derived from delivering high quality service and resources in the most responsive, flexible, and innovative way. ICONMA invests in people and resources with a single goal: To provide our customers with the highest quality service in the most responsive manner. Through its network of offices, ICONMA provides the resources to help clients maintain their competitive advantage.

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