Quality Control Analyst

Summary 

Pace Life Sciences, is a premier Contract Research and Development Organization located in San Diego, CA, providing pharmaceutical development services for small molecules, biologics, oligonucleotide therapeutics, and other biopharmaceutical drug candidates.

We are currently seeking a Quality Control (QC) Analyst to support the rapid growth of our organization. Responsible for day-to-day testing of Good Laboratory Practice / Good Manufacturing Practice (GLP/GMP) samples including but not limited to: incoming identity (ID), in-process, release, and stability. Works under supervision of QC manager to ensure all testing is complete to the highest standard, facilitating batch release and on time completion of stability studies.

Essential Duties and Responsibilities include the following, but not limited to:

This class specification lists the major duties and requirements of the job and is not all-inclusive. Incumbent(s) may be expected to perform job-related duties other than those contained in this document and may be required to have specific job-related knowledge and skills. 

General Responsibilities:

• Execute QC testing of incoming materials, in process GMP samples, GMP release samples, and stability testing of GMP and GLP material. 
• Support maintenance of the  QC lab in GMP compliant state with appropriate equipment and software installation, operation, and performance qualification (IOPQ) documentation and routine preventative maintenance (PM) servicing
• Execute and oversee specialized analytical testing and generation of technical documents including SOPs, testing forms
• Support Quality Assurance (QA) in drafting of laboratory investigations, out of specification (OOS), deviations as needed
• Collect, assess and report data with a clear understanding of its reliability, interpret findings, and draw authoritative conclusions and recommendations so that their significance can be appreciated.
• Regularly interact with clients to keep them abreast of project progress
• Interface with clients to develop an in-depth understanding of client objectives and define solutions to meet their program requirements by writing persuasive proposals for projects.
• Support the writing and review of interim and final reports.
• Recommend to management when equipment needs to be upgraded and/or replaced

Required Education and/or Experience:

To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required.

Bachelor's degree in chemistry, biology, environmental science, or a closely related field; AND zero to two (0-2) years of experience, OR an equivalent combination of education, training, and experience. 

• Ability to follow and execute established testing standard operating procedures (SOPs)
• Attention to detail when filling out test forms
• Receptive to instruction and coaching from senior lab members
• Prior HPLC experience preferred
• Prior experience with Good Documentation Practices (GDP) preferred
• Prior experience with GLP and GMP preferred
• Prior experience with data integrity preferred

Physical/Mental Requirements:  The physical demands described herein are representative of those that must be met by an employee to successfully perform the essential functions of the job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. Mobility to work in a lab and office setting, use standard office and lab equipment and stamina to sit for extended periods of time; exerting up to 20 pounds of force occasionally and/or up to 10 pounds of force frequently to lift, carry, push, pull or move objects; vision to read printed materials and computer screens; and hearing and speech to communicate in person or over the telephone.

Working Environment: Work is performed in a lab and office setting. Work is subject to chemicals, fumes, gasses, noxious odors and related items in a lab setting.

Pace Benefits include: Three options for Medical, HSA, FSA, Dental, Vision, LTD, STD, Life Insurance, Voluntary Life Insurance, 401k and 401k employer match, vacation, sick leave, floating holiday, and holiday time off.

Pace Life Sciences, LLC is an Equal Opportunity Employer and will not discriminate against any applicant for employment on the basis of race, age, religion, sex, veterans, individuals with disabilities, sexual orientation, or gender identity. 

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