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Quality Assurance Associate
Pharmaron San Diego, CA
Apply
$102k-122k (estimate)
Full Time 4 Days Ago
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Pharmaron is Hiring a Quality Assurance Associate Near San Diego, CA

Position: Quality Assurance Associate
Department: Quality Assurance
FLSA Status: Non-Exempt
Location: Carlsbad, CA (On-site)
Position Description: The Quality Assurance Associate will play a vital part in maintaining and enhancing our Quality Systems. Reporting directly to the Senior Manager QA, you'll actively participate in various Quality Systems, lead investigations, support controlled document systems, and ensure regulatory compliance.
Primary Responsibilities:
  • Actively contribute to all Quality Systems such as Deviations, Non-conformances Change Control, CAPA, Risk Assessments, Internal Audits
  • Lead or assist in investigation activities, perform root-cause analysis, and identify effective corrective actions and process improvements
  • Support the controlled document systems, including authoring and revising QAU SOPs
  • Oversee the RODAC Testing by QC Personnel and ensure results are reviewed and properly archived
  • Participate in Regulatory Inspections and Client Audits, as needed
  • Cross train to provide secondary support for performance of GLP study audits
  • Identify and lead continuous improvement initiatives
  • Review and update QA SOPs as needed per internal procedure for controlled documents
  • Assist in maintaining the facility in an inspection ready state
  • Serve as QAU representative on cross functional project teams
  • Communicate effectively with co-workers, management and clients
  • Additional duties, as required
Candidate Requirements:
  • A Bachelor's degree in Science, preferably in biology or similar field
  • Two years of Quality Assurance experience within the pharmaceutical or biotechnology industry, in a regulated environment; GLP or other regulatory experience is desired
  • ISO 9001:2015 Quality Systems experience, a plus
  • An ability to organize, understand, and present complex information at a level that is appropriate for technical and non-technical backgrounds
  • Attention to detail and analytical thinking proficiency
  • Excellent communication skills, interpersonal skills and organizational skills
  • Strong technical writing skills
Benefits:
Pharmaron cares about our work community and offers a variety of benefits allowing employees the opportunity to customize a benefits package that meets their personal needs. Company benefits include the following:
  • Medical, Dental & Vision Insurance Plan with Employer Contribution
  • Health Reimbursement Account Funded by Employer
  • Healthcare & Dependent Care Flexible Spending Accounts
  • Employee Life and AD&D Insurance 100% Employer Paid
  • Voluntary Life and AD&D Insurance for Employee, Spouse & Child(ren)
  • Short and Long Term Disability 100% Employer Paid
  • 401k with Employer Match
  • Employee Assistance Program
About Pharmaron
Pharmaron (Stock Code: 300759.SZ/3759.HK) is a premier R&D service provider for the life sciences industry. Founded in 2004, Pharmaron has invested in its people and facilities, and established a broad spectrum of research, development and manufacturing service capabilities throughout the entire drug discovery, preclinical and clinical development process across multiple therapeutic modalities, including small molecules, biologics and CGT products. With over 19,000 employees, and operations in China, the U.S., and the U.K., Pharmaron has an excellent track record in the delivery of R&D solutions to its partners in North America, Europe, Japan and China.
Pharmaron is proud to be an Equal Employment Opportunity and Affirmative Action employer.
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Job Summary

JOB TYPE

Full Time

SALARY

$102k-122k (estimate)

POST DATE

05/07/2024

EXPIRATION DATE

05/20/2024

WEBSITE

pharmaron.com

HEADQUARTERS

IRVINE, CA

SIZE

500 - 1,000

FOUNDED

2004

CEO

BOLIANG LOU

REVENUE

$5M - $10M

INDUSTRY

Scientific Services

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About Pharmaron

Founded in 2004, Pharmaron is a cutting-edge, fully integrated pharmaceutical R&D service platform supporting the life science industry. The company has invested in its people and facilities and established its comprehensive service offerings throughout the pharmaceutical R&D lifecycle. With operations in China, the US and the UK staffed by more than 11,000 employees, Pharmaron has an excellent track record in delivering end-to-end R&D solutions to its partners globally and enabling them to accelerate their novel drug discovery and development process. Pharmaron is a contract research organiza ... tion (CRO). Services: * Synthetic, medicinal and analytical chemistry services * Biology services * DMPK services * Pharmacology services * Drug safety assessment services * Radiochemistry and isotopically labelled metabolism services * Chemical & pharmaceutical development services * Clinical development services www.pharmaron.com CRO - Contract Research Organization Library Synthesis CADD Bioorganic Chemistry Discovery Process Chemistry Radiolabelled Chemical Synthesis ChemInformatics in vitro Biology in vitro Screening Structural Biology in vivo Pharmacology Animal Disease Models ex vivo Pharmacology Biomarkers in vitro ADME in vivo PK PKPD QA Regulatory Affairs Discovery Biologics Process Chemistry API Manufacturing Material Science Formulation Development Drug Product Manufacturing Toxicology Safety Pharmacology Genetic Toxicology DART Pathology Immunotoxicity Bioanalytical 14C / Carbon-14 Radiosynthesis 3H / Tritium Radiosynthesis QWBA mARG Clinical AME Mass Balance Metabolite Profiling Microdosing Phase 0 Absolute Bioavailability DDI First-in-Human (FIH) Thorough QT(TQT) Ethnobridging More
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The following is the career advancement route for Quality Assurance Associate positions, which can be used as a reference in future career path planning. As a Quality Assurance Associate, it can be promoted into senior positions as a Quality Assurance Specialist IV that are expected to handle more key tasks, people in this role will get a higher salary paid than an ordinary Quality Assurance Associate. You can explore the career advancement for a Quality Assurance Associate below and select your interested title to get hiring information.

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If you are interested in becoming a Quality Assurance Associate, you need to understand the job requirements and the detailed related responsibilities. Of course, a good educational background and an applicable major will also help in job hunting. Below are some tips on how to become a Quality Assurance Associate for your reference.

Step 1: Understand the job description and responsibilities of an Accountant.

Quotes from people on Quality Assurance Associate job description and responsibilities

Quality Assurance Associates conduct audits, training programs as well as documentation reviews and analysis.

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Prepare an efficient training program for all quality systems.

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Examined and compared given photos to ensure accuracy and required photos meet quality standards.

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Train and provide assistance to less experienced members of the QA team on quality procedures, protocols, and documentation.

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Step 2: Knowing the best tips for becoming an Accountant can help you explore the needs of the position and prepare for the job-related knowledge well ahead of time.

Career tips from people on Quality Assurance Associate jobs

Quality Assurance Specialist roles will typically be looking for the skills previously outlined.

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Step 3: View the best colleges and universities for Quality Assurance Associate.

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