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Quality Control Chemist

2 months ago

Frederick, United States Rose International Full time

BACK END SWING. Wed-Sat 1pm-1130pm.

FRONT END SWING. Sun-Wed 1pm-1130pm.

IMPORTANT: For the first 7 weeks of the assignment, all contractors are required to work Mon-Fri (07:30-16:00) 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.

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.

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.

Assist 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.

  • **Only those lawfully authorized to work in the designated country associated with the position will be considered.**

  • **Please note that all Position start dates and duration are estimates and may be reduced or lengthened based upon a client’s business needs and requirements.**

Benefits:

For information and details on employment benefits offered with this position, please visit here. Should you have any questions/concerns, please contact our HR Department via our secure website.

California Pay Equity:

For information and details on pay equity laws in California, please visit the State of California Department of Industrial Relations' website here.

Rose International is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, age, sex, sexual orientation, gender (expression or identity), national origin, arrest and conviction records, disability, veteran status or any other characteristic protected by law. Positions located in San Francisco and Los Angeles, California will be administered in accordance with their respective Fair Chance Ordinances.

If you need assistance in completing this application, or during any phase of the application, interview, hiring, or employment process, whether due to a disability or otherwise, please contact our HR Department.

Rose International has an official agreement (ID #132522), effective June 30, 2008, with the U.S. Department of Homeland Security, U.S. Citizenship and Immigration Services, Employment Verification Program (E-Verify). (Posting required by OCGA 13/10-91.).