Pharmaceutical Quality Assurance Executive

San Ramon, Ca, USA - On-site

ACHNET Demo

San Ramon, Ca, USA

Full-time

Entry-level (0-2 years of experience)

Job Overview

ACHNET Demo is seeking a highly motivated and detail-oriented Pharmaceutical Quality Assurance Executive to join our dynamic team. This entry-level position is ideal for recent graduates with a strong academic foundation in pharmaceutical sciences and a keen interest in ensuring the quality and compliance of our pharmaceutical products. The successful candidate will contribute to maintaining high standards of quality throughout the product lifecycle, from development to post-market surveillance.

Key Responsibilities

1. Assist in the development, implementation, and maintenance of Quality Management Systems (QMS).
2. Participate in batch record review and release processes to ensure compliance with regulatory requirements and internal procedures.
3. Support the investigation of deviations, out-of-specification (OOS) results, and customer complaints, contributing to root cause analysis and corrective/preventive actions (CAPA).
4. Assist in the qualification and validation of equipment, processes, and analytical methods.
5. Contribute to internal and external audits by preparing documentation and supporting audit activities.
6. Maintain accurate and organized quality records and documentation.
7. Stay abreast of relevant regulatory guidelines and industry best practices in pharmaceutical quality assurance.

Educational Qualifications

1. Bachelor's degree in Pharmacy, Pharmaceutical Sciences, Chemistry, Biology, or a related scientific discipline.

Must-Have Skills

1. Solid understanding of Pharmacology (drug action), Medicinal Chemistry, Pharmaceutics (formulation), Pharmacognosy (natural products), Pharmaceutical Analysis, Biochemistry, and Anatomy & Physiology.
2. Excellent attention to detail and accuracy.
3. Strong analytical and problem-solving skills.
4. Proficiency in Microsoft Office Suite (Word, Excel, PowerPoint).
5. Effective written and verbal communication skills.
6. Ability to work independently and as part of a team.

Good-to-Have Skills

1. Familiarity with Good Manufacturing Practices (GMP) and Good Laboratory Practices (GLP).
2. Knowledge of regulatory affairs in the pharmaceutical industry.
3. Experience with quality management software.
4. Internship or co-op experience in a pharmaceutical or related industry.

Pay Rate/Salary

Competitive salary commensurate with entry-level pharmaceutical roles and qualifications.

Number of Openings

45