Quality Control Chemist - IVARITE is looking for qualified Quality Control Chemist - I in Frederick, MD.Job Title: Quality Control Chemist - ILocation: Frederick, MDContract Duration: 12 months (Possible Extension)Pay Rate Range: $28.00/hr. to $30.07/hr. on W2Work Authorization: Only USC or GCOnsite - Shift flexibility preferredWed-Saturday: Time: Day 3PM - 1:30AM ESTImportant: For the first 7 weeks of the assignment, all contractors are required to work Mon-Fri ) to complete New Hire Orientation and Manufacturing On-boarding Technical Training.
After 7 weeks, the contractor is deployed onto their agreed upon shift. New hires will need to be completed.Here's What You'll DoJob Description: Duties: Responsibilities (including 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 maintenanceAuthor 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.Basic Qualifications:Bachelor's Degree ORAA Degree and 2+ years' experience in biotechnology or related field and Quality Control experience ORHigh School Degree and 3+ years' experience in biotechnology or related field and Quality Control experiencePreferred 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.Benefits:Health Insurance: Medical, dental, and vision coverageRetirement Plans: Participation in a company-sponsored retirement savings plan.Legal Service Plans: Offering access to attorneys for legal advice and representation.If this opportunity interests you, please respond by clicking on EasyApply. Know someone who would be perfect for this role? Refer to us and if they are hired, you could be eligible for our employee referral bonus!
Help us grow our team with top talent from your network. VARITE is committed to creating a diverse environment and is proud to be an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, gender, gender identity or expression, sexual orientation, national origin, genetics, disability, age, or veteran status.