QC Specialist, Analytical in El Segundo, CA at APEX Systems
Company: Apex Systems
Location: El Segundo
Posted on: May 19, 2019
Job #: 940130
Apex is searching for a--QC Associate--in the Los Angeles area.
This is a great opportunity to work with an industry leader!
Responsibilities (include but are not limited to):
- Perform testing of raw materials, intermediates and final
products by following analytical methods.
- Maintain, calibrate and operate equipment and instruments
supporting cell bioassays, Flow Cytometry, ELISA and PCR
- Track and test products according to Stability protocols.
- Work with internal and external resources to maintain lab in an
- Monitor and trend data, complete routine record review of test
data and related documents for in-process testing, drug substance
and drug product release. Generation of CoAs for product
- Assist in the preparation of dossiers and data packages for
interactions between company and Regulatory agencies. Interact with
agents from Regulatory agencies and participate in Pre-Approval
- Develop, revise and review SOPs, qualification/validation
protocols and reports.
- Conduct investigations regarding out of specifications (OOS)
results. Address and manage 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.
- Strong knowledge of GMP, SOPs and quality control
- Identifying, writing, evaluating, and closing OOS's and
- Proficient in MS Word, Excel, Power Point and other
- Strong written and verbal communication skills.
- Ability to communicate and work independently with
- Required: Bachelor or Master's degree in biotechnology or
related field with 4 - 5 years of Quality Control experience or PhD
molecular biologist or biochemist preferred with 1-2 years of
Quality Control experience.
- The ideal candidate is well versed in various analytical
techniques such as Flow Cytometry, ELISAs, PCR, and cell bioassays
and other applicable methods to the testing of
- Working knowledge of quality systems and regulatory
requirements (21 CRF Part 11/210/211).--
- Preferred: Experience in the biotech and/or pharmaceutical
- Potential shifts are Sunday - Wednesday or Wednesday -
Saturday. Business need may require alternate work schedule, such
as swing shift hours.
For immediate consideration please email resume
Apex is an Equal Employment Opportunity/Affirmative Action
Employer. All qualified applicants will receive consideration for
employment without regard to race, color, religion, sex, age,
sexual orientation, gender identity, national origin, disability,
protected veteran status, or any other characteristic protected by
law. Apex will consider qualified applicants with criminal
histories in a manner consistent with the requirements of
applicable law. If you have visited our website in search of
information on employment opportunities or to apply for a position,
and you require an accommodation in using our website for a search
or application, please contact our Employee Services Department at
Keywords: Apex Systems, Los Angeles , QC Specialist, Analytical in El Segundo, CA at APEX Systems, Other , El Segundo, California
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