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Quality Control Associate Ii

Location:
Apex, NC
Salary:
100,000
Posted:
April 08, 2024

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Resume:

Evan Brewer

919-***-**** ad4uuu@r.postjobfree.com

BACKGROUND

Highly skilled Biochemistry professional with extensive experience in Quality Control, laboratory research, and compliance within the pharmaceutical industry. Adept at performing a wide range of biochemical assays and analyses, ensuring GMP compliance, and maintaining laboratory instruments. Proven expertise in ELISA assays, CE-SDS assays, SDS-PAGE, and various other analytical techniques.

RELEVANT EXPERIENCE

QC LEAD ASSOCIATE II, BIOCHEMISTRY JAN 2023 – PRESENT

Durham, NC

Performing ELISA assays, Performing CE-SDS assays, Performing SDS-PAGE.

Performing pH and appearance assays.

Use of LIMS system and solutions preparation.

QC ANALYST III, QC BIOCHEMISTRY MEDICAGO MAY 2022 – DEC 2022

Durham, NC

Maintaining GMP compliance and use of LIMS system.

Perform ELISA assays, Perform BCA, Perform UPLC.

Participated in audit activities with Health Canada.

ASSOCIATE SCIENTIST II BIOGEN RESEARCH FEB 2010 – MAY 2022

Triangle Park, NC

Maintaining GMP compliance and trained new employees on various assays and day to day lab responsibilities. Led lab investigations and control qualifications.

Appearance, auto-injector functionality, pH and osmolality (vapor, freezing point) testing.

Performing SDS-PAGE, developed a training guide for SDS-PAGE.

Performing CE-SDS (SME and assay manager) with PA800 and PA800 plus systems.

Performing carbohydrate analysis, including glycan and TSA assays.

Performing Size Exclusion, Strong Anion Exchange and Ion Exchange Chromatography.

Protein concentration determination by UV absorbance, reverse phase HPLC and refractive index.

Performing various titer assays. Performed solution prep and day to day lab functions.

Sample receiving and assignment of testing in LIMs system and utilizing SmartQC system.

Technical report writing (method reviews, annual method reviews, control qualifications, retest protocols/reports). Performed method transfers and validations.

Writing lab exceptions, lab investigations and deviations in TrackWise.

Performing deamidation, oxidation and peptide map assays (SME on all).

Peptide mapping using UPLC analysis (SME and assay manager).

Proficient with Waters and Agilent HPLC instruments, as well as the Waters UPLC.

Partnered with various groups within the organization to support projects.

Participated in audits internally and with the FDA, EMA, and contractors.

Experience in troubleshooting multiple HPLC, UPLC and CE-SDS assays.

ASSOCIATE SCIENTIST TALECRIS BIOTHERAPEUTICS JUL 2009 – FEB 2010

Triangle Park, NC

Performing viral titrations and off-testing cell plates.

Maintaining virus inventory, maintaining GLP compliance.

Performing cell culture, including the passage and plating of various cell lines.

Virus purification and propagation.

Performing procedures to remove/inactivate pathogens during the manufacture of plasma-derived products.

HDR sample preparation and performing Western Blots.

Working with BSL-2 materials (Hepatitis A, Hepatitis B, and scrapie)

Acting as Subject Matter Expert for balances and water baths for the two groups.

STUDENT RESEARCHER NORTH CAROLINA STATE MAY 2007 – DEC 2007

Raleigh, NC

Working in a tissue culture hood growing, maintaining and plating cells from the HepG2 and Cos1 cell lines, as well as performing cell transfections and cell treatments.

Performing western blots, ELISA, and SDS-PAGE.

Making buffers/solutions, autoclave sterilization, maintaining a lab notebook, using MS Word and Excel, and developing and presenting a symposium poster.

EDUCATION AND CERTIFICATIONS

BA – BIOCHEMISTRY, NORTH CAROLINA STATE UNIVERSITY – MAY 2009



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