QC Specialist - Biochemistry job St. Joseph Missouri
QC Specialist - Biochemistry job St. Joseph Missouri
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QC Specialist - Biochemistry Job



Employer Name: SpiderID: 8493669
Location: St. Joseph, Missouri Date Posted: 3/18/2019
Wage: $18.00-$22.00 hour Category: Biotech
Job Code:
Number Of Openings: 1

Job Description:
Do you have QC experience and a Biochemistry background? Kelly Services is looking for you. This is a great temp to hire career opportunity. Call 816-233-3411 today for more information and to apply.

Responsibilities include, but are not limited to:

Conduct routine and non-routine Biochemistry-based analysis of raw materials, in-process materials, finished goods, environmental monitoring samples, and stability samples.
Prepare test protocols and project data.
Ensure the QC lab is held to cGMP, safety, and environmental standards.
Generate, review and approve data to ensure accuracy and regulatory compliance.
Prepare, review and approve Certificate of Analyses, OOS/OOT investigations, and deviations during testing.
Develop and qualify/validate new testing methods. Write and revise testing methods.
Develop specifications and justification of specifications.
Train other analysts to perform laboratory procedures and assays.
Prepare and approve QC standard operating procedures.
Support equipment validation, calibration, and maintenance.
Serve as SME between QC and other departments, vendors, or contractors.
Prepare method validation protocols/reports and other analytical study reports.
Supply, write or review quality control data in regulatory submissions.
Participate in internal assessments and audits as required.
Recommend new technologies and methods.


Job Requirements:
Qualifications/Skills required:

BA/BS in Biochemistry, Biological Sciences, Pharmaceutical Sciences, or closely related field.
Ten years of experience in cGMP at an operational level supporting manufacturing in a pharmaceutical or biotech environment or experience in GLP/GCP. Advanced degree will be considered in lieu of experience.
Experience with Phase 1, 2, or 3 and / or commercial drug substance/drug product manufacturing.
Experience in method development/validation.
Experience in protein and other bio-macromolecular testing and characterization and immunological testing. Other technical skills in biochemistry, cell biology, immunology, or microbiology.
Knowledge of pharmaceutical cGMPs (US and EU).
Experience in preparation of CMC sections of US or EU regulatory filing.
Knowledge of VICH, cGMP, FDA, USDA, and European Medicines Agency guidance, as well as US and international pharmacopeia, as related to QC activities.
Proficient computer, documentation, communication and organizational skills required.
Attention to detail, problem-solving skills, and ability to work in a team environment.


Job Criteria:
Start Date:
Position Type: Full-Time Temporary
Years of Experience Required:
Education Required: Bachelors
Overnight Travel: None
Vacation Time:


Job Benefits:
Health/Dental Benefits, Paid Holidays, Vacations, and Sick Leave

Contact Information:
Contact Name: Kari Beever Company Type: Staffing Agency
Company: Kelly Services Phone: 816-233-3411
Street: 5506 Corporate Dr Ste 1740 Fax: 816-279-7331
City: St Joseph
State: Missouri
Zip: 64506
Web Site: www.mykelly.com

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