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Quality Control
Duarte, CA
Position Summary
Responsible for assisting the Quality Control Manager in achieving compliance with all Federal and State accrediting agency requirements in the testing of biopharmaceutical and genetic products manufactured in the Center for Biomedicine and Genetics (CBG). Performs quality control assays, release tests and assay development tasks. Provides qualification and validation support for manufacturing processes and quality assurance procedures that are essential to the cGMP production of biomedical products, including appropriate and accurate documentation.
If interested, please send your resume to Schuyler Harris
Position Accountabilities
The following are essential job accountabilities:
1.
Performs release testing on manufactured products following established SOP. Develop and adapt new procedures for testing when necessary. Complete all documents associated with the testing in compliance to cGMP.
2.
Assists in creating, reviewing and revising Standard Operating Procedures as necessary.
3.
Assists in internal inspections and audits to ensure compliance with Federal Drug Administration (FDA) regulations and CBG procedure requirements.
4.
Participate in general laboratory activities as assigned by supervisor.
5.
Complete and maintain all training required to perform assigned tasks.
6.
Cooperates with other performance improvement and compliance activities within the department and in the institution.
7.
Maintains current knowledge of analytical techniques and industry practices.
8.
Possess and demonstrate integrity and honesty in maintaining confidentiality. Follows established departmental policies, procedures, objectives, performance improvement, attendance, safety, environmental, and infection control guidelines.
9.
Performs other related duties as requested by supervisor.
Position Qualifications
Minimum Education
Bachelor of Science or Bachelor of Arts with coursework in biology and chemistry required.
Minimum Experience
2-3 years post-Bachelors degree work experience in a laboratory, or 1-2 years post-Masters degree work experience in a laboratory.
Required Courses/Training
Basic Biology (Molecular and Cellular), Chemistry (Inorganic, Organic and Biochemistry)
Requirements: Other
Foster and promote a positive image and professional appearance; Organized and efficient; Demonstrate proficiency in basic laboratory skills; Excellent writing and computer skills; Able to correctly use technical terms and abbreviations.
Preferred Education
Bachelor or Master degrees with relevant laboratory working experiences.
Experience: Other
Experience working in a cGMP manufacturing environment desirable.
Preferred Courses/Training
Modern molecular biology, protein chemistry, biostatistics, biosafety training, chemical safety training, cGMP principles and practices.
Preferred field of expertise
Biotechnology, Pharmaceutical industry experience
Aptitude: Req./Pref.
Excellent written and oral communication skills, team player, self-motivated excellent personal hygiene; Practice good judgment in all professional activities; Ability to analyze data and compose reports; Ability to develop and update policies and procedures; Ability to set and model professional work standards;
Software
Microsoft Office, Access, Excel, Windows NT, Word and miscellaneous device control software.
Instruments / Equipment: Req./Pref
PCR and electrophoresis equipment, Coulter Counter and flow cytometer, centrifuges, microscopes, pH meter, biosafety cabinet and incubator, plate readers
Working Conditions
State-of-the-art GMP biologics manufacturing facility; Atmosphere and environment associated with an office setting; Atmosphere and environment associated with a laboratory; Tobacco-free campus; Subject to many interruptions; Subject to occasional long, irregular hours; Work under deadline pressure; May require a flexible work schedule; Subject to changing priorities and work assignments
Required Protective Equipment
Lab coats, goggles, and gloves required in the laboratory. Other safety precautions and practices as specified by safety regulations.
Physical Demands
Light physical effort (lift/carry up to 20 lbs.); Frequent walking; Some reaching, stooping, bending, kneeling, crouching; Tasks require focused attention to details;
Communication
Requires excellent oral and written communication & organizational skills; Requires a high degree of independence, responsibility and follow-through; Must have college level proficiency in English grammar and spelling.
If interested, please send your resume to Schuyler Harris
EEO Employer
Apex Systems is an equal opportunity employer. We do not discriminate or allow discrimination on the basis of race, color, religion, creed, sex (including pregnancy, childbirth, breastfeeding, or related medical conditions), age, sexual orientation, gender identity, national origin, ancestry, citizenship, genetic information, registered domestic partner status, marital status, disability, status as a crime victim, protected veteran status, political affiliation, union membership, 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 or
