This role leads and documents quality control investigations in a pharmaceutical laboratory, including out-of-specification results, laboratory errors, equipment failures, and test method issues. The position works with QC, QA, customers, and cross-functional teams to identify root causes, develop effective CAPAs, meet investigation deadlines, maintain compliance with cGMPs and SOPs, and drive critical investigations to closure.

Qualifications:

• Bachelor’s with major in Chemistry or related scientific discipline with a minimum of 6 years of experience in a QC laboratory environment OR equivalent combination of relevant education and experience may be substituted as appropriate

• Investigations experience including root cause analysis, writing, and CAPA identification

Monday - Friday 8am-5pm

Responsibilities:

• Work with QC and cross functional team as needed to meet required QC investigation deadlines in a proficient manner, while driving to root cause, and identifying the appropriate & effective corrective and preventive action.

• Ensure QC investigations are initiated in a timely manner, initial impact completed and submitted for QA reviews within stipulated timeframes

• Conduct and document investigations as needed, while also working with customers as required.

• Conduct, and document OOS investigations, including coordination with customers as required by quality agreements and regulatory commitments.

• Apply 6M, 5 Why or fishbone analysis to drive root cause

• All investigations will follow procedures in accordance with cGMP’s.

• Work with the team to document and drive critical investigations to closure.

• Maintain metrics for the laboratories to identify CAPA opportunities including, analyst error rate, equipment failure rate, and test method issues.

• Ensure all investigations are executed in full compliance with cGMPs, Curia SOPs, and global quality standards.

• Work with the team to develop investigation strategies to meet customer commitments and requirements.

• Provide investigation updates to cross functional areas and management, as required.

• Develop an expertise in documenting investigations and create templates to use for ease of reference and consistency.

• Identify CAPA’s and update training modules to reduce analyst error rate

• Work independently and with the QC team as the primary investigator on all critical laboratory related investigations.

Quality Control Investigations, CAPA Identification and Development, Laboratory Error Investigations, Pharmaceutical Quality Control

Equal Opportunity Employer / Disabled / Protected Veterans

The Know Your Rights poster is available here:
https://www.eeoc.gov/sites/default/files/2023-06/22-088_EEOC_KnowYourRights6.12.pdf

The pay transparency policy is available here:
https://www.dol.gov/sites/dolgov/files/ofccp/pdf/pay-transp_%20English_formattedESQA508c.pdf

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.
https://e-verify.uscis.gov/web/media/resourcesContents/E-Verify_Participation_Poster_ES.pdf

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.