Job Description

This role is responsible for reviewing pharmaceutical laboratory testing and technical data to ensure accuracy, data integrity, and compliance with cGMP requirements, company SOPs, and applicable compendial standards. The position also supports quality management documentation, employee training, raw material release, production suite commissioning, cleaning verification, inspections, and communication with management regarding laboratory performance.

Qualifications:

• Bachelor’s Degree in Chemistry or related field and a minimum of three years’ relevant industry experience; OR Master’s degree and one-year relevant experience

Preferred experience working in cGMP or GLP pharmaceutical industry environment

Responsibilities:

• Review quality control testing for compliance with internal SOPs and specifications

• Assist in technical data review of the raw data generated for various compendial testing (such as USP/NF, EP, JP, etc.) as well as Curia In-house and client methodologies for various client projects to ensure data accuracy and integrity

• Collaborate with lab personnel for data review per cGMP compliance, data integrity

• Ensure all tests are per cGMP compliance and in compliance with the company’s standard operating procedures

• Provide training to new hires as needed. Attend internal and external training on related subjects, cGMP compliance and data integrity, new techniques and procedures

• Report back to appropriate management as to personnel performance, highlighting those areas and individuals in need of improvement as well as those exceeding expectations

• Author, review, and/or approve Quality Management System documents, including, but not limited to, change controls, SOPs, deviations, CAPAs, etc.

• Provide support on Raw Material release and GMP production suite commissioning activities when necessary

• May perform QA cleaning verification and inspection activities when required

• Other duties as assigned.

Quality Control Testing, Quality Assurance, Laboratory Testing, Raw Data Review, Pharmaceutical Manufacturing

Equal Opportunity Employer / Disabled / Protected Veterans

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For temporary assignments lasting 13 weeks or longer, AppleOne is pleased to offer major medical, dental, vision, 401k and any statutory sick pay where required.

We are committed to working with and providing reasonable accommodations to individuals with disabilities. If you need a reasonable accommodation for any part of the employment process, please contact your staffing representative who will reach out to our HR team.

AppleOne participates in the E-Verify program in certain locations as required by law. Learn more about the E-Verify program.

We also consider for employment qualified applicants regardless of criminal histories, consistent with legal requirements, including, if applicable, the City of Los Angeles’ Fair Chance Initiative for Hiring Ordinance. Pursuant to applicable state and municipal Fair Chance Laws and Ordinances, we will consider for employment-qualified applicants with arrest and conviction records, including, if applicable, the San Francisco Fair Chance Ordinance. For Los Angeles, CA applicants: Qualified applications with arrest or conviction records will be considered for employment in accordance with the Los Angeles County Fair Chance Ordinance for Employers and the California Fair Chance Act.

Job Tags

Temporary work

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