QA Specialist II/III (Pharma)

QA Specialist

II / III

•Batch Record Review ??

Location:

Carlsbad, CA ??

Schedule:

Monday-Friday | 8:00 AM•5:00 PM (Flexible start times based on production needs; some team members begin as early as 6:00 AM) ??

Pay Range:

QA Specialist II:

$35•$45/hr

QA Specialist III:

$45•$58/hr 1 year contract with possibility of extension/conversion About the Opportunity We are seeking a QA Specialist II or III to join a global pharmaceutical manufacturing organization supporting critical Quality Assurance operations within a GMP-regulated environment. This is a contract opportunity with potential for extension based on business needs. This role will focus heavily on batch record review and documentation oversight in support of a major end-of-year validation initiative. The ideal candidate will bring strong QA experience within pharma, biotech, or biopharma manufacturing environments and possess exceptional attention to detail when reviewing complex GMP documentation and chromatographic data. This is an excellent opportunity to join a highly respected global API manufacturer headquartered in Switzerland and work alongside industry leaders in pharmaceutical manufacturing and quality systems. Key Responsibilities Perform detailed review of production batch records to ensure compliance with GMP requirements and internal quality standards Review highly detailed documentation packages ranging from several hundred to tens of thousands of pages Review chromatograms and supporting analytical documentation for accuracy and completeness Identify discrepancies, deviations, or compliance concerns and escalate findings to Quality Management Support quality systems activities including documentation review, archiving, scanning, and record verification Verify scans of batch production records (BPRs), chromatograms, and GMP documentation prior to archival Maintain accurate organization and archival of GMP records and supporting documentation Provide support during internal, customer, and regulatory audits Assist with continuous improvement initiatives and quality system support activities Collaborate cross-functionally with Manufacturing, QC, and Quality teams to ensure compliance and documentation accuracy Qualifications QA Specialist II Bachelor's degree in a scientific discipline preferred 3-5 years of QA experience within pharmaceutical, biotech, or biopharma manufacturing environments QA Specialist III Bachelor's degree in a scientific discipline preferred 5-7 years of QA experience within pharmaceutical, biotech, or biopharma manufacturing environments Additional Requirements Strong experience reviewing batch records within GMP-regulated manufacturing environments Strong understanding of GMP documentation practices and quality systems Experience reviewing chromatograms strongly preferred Exceptional attention to detail and organizational skills Ability to manage large volumes of documentation in a fast-paced environment Proficiency with Microsoft Office applications Associate degree candidates with equivalent GMP experience will also be considered

Additional Information Team Size:

Approximately 10 employees

Reports To:

QA Manager Interview Process:

One onsite interview (~1 hour) with quick decision turnaround

Start Date:

ASAP Background check and drug screen required INDBH #LI-ES1