Analytical Scientist

AppleOne Employment Services; Arecibo (PR); On-site; USD 60,000 - 80,000; Full time

Benefits offered by this job

Major medical

Dental

Vision

401k

Sick pay

Job summary

AppleOne Employment Services is seeking an experienced Analytical Scientist for a pharmaceutical manufacturing environment in the United States. The role requires hands-on analytical laboratory work in a regulated setting with emphasis on GMP compliance, validation, documentation, and data integrity.

Responsibilities include performing analytical testing, supporting method validation/transfers, maintaining documents, investigating OOS/OOT results, and collaborating with Quality, Manufacturing,

Qualifications

• Bachelor's degree in a related scientific discipline.
• 3–5 years of analytical laboratory experience in a regulated environment.
• Knowledge and practical experience with GMP and cGMP requirements.
• Experience with analytical method validation, verification or transfer.
• Knowledge of laboratory investigations and data integrity principles.
• Experience preparing and reviewing validation protocols/reports.
• Familiarity with laboratory instrumentation and analytical techniques.
• Strong technical writing and documentation skills.
• Ability to interpret data, troubleshoot issues, and support corrective actions.

Responsibilities

• Perform analytical testing of materials and samples in accordance with GMP, SOPs, and regulatory requirements.
• Support analytical method validation, verification, transfers, and related activities.
• Prepare, review, and maintain analytical documentation and validation files.
• Investigate OOS/OOT and atypical results, supporting root cause analysis and corrective actions.
• Review analytical data for accuracy, completeness, and compliance.
• Collaborate with Quality, Manufacturing, Validation, and Regulatory Affairs to support compliance and continuous improvement initiatives.

Skills

Analytical testing

GMP/cGMP experience

Method validation/verification

Documentation & recordkeeping

Data integrity

Laboratory investigations (OOS/OOT)

Cross-functional collaboration

Education

Bachelor's degree in Chemistry, Pharmaceutical Sciences, Biochemistry, Biology

Job description

We are seeking an experienced Analytical Scientist for pharmaceutical manufacturing environment. This role is ideal for a scientist with hands-on analytical laboratory experience who understands GMP compliance, analytical testing, validation, documentation, laboratory investigations, and data integrity. The Analytical Scientist will support analytical services for raw materials, in-process samples, finished products, and stability samples while working closely with Quality, Manufacturing, Validation, and Regulatory Affairs teams. This is a strong opportunity for a detail-oriented scientific professional who enjoys working in a regulated environment where accuracy, compliance, and continuous improvement are valued.

Key Responsibilities

• Perform analytical testing of raw materials, in-process samples, finished products, and stability samples in accordance with GMP, SOPs, and regulatory requirements.
• Support analytical method validation, verification, transfers, and related laboratory activities.
• Prepare, review, and maintain analytical documentation, protocols, reports, laboratory records, and validation documentation.
• Investigate OOS, OOT, and atypical laboratory results, including support for root cause analysis and corrective actions.
• Review analytical data for accuracy, completeness, compliance, and data integrity.
• Collaborate with Quality, Manufacturing, Validation, and Regulatory Affairs teams to support laboratory compliance and continuous improvement initiatives.

Required Qualifications and Skills

• Bachelor's degree in Chemistry, Pharmaceutical Sciences, Biochemistry, Biology, or a related scientific discipline.
• 3 to 5 years of analytical laboratory experience, preferably within pharmaceutical, biotechnology, medical device, or another regulated industry.
• Knowledge and practical experience with GMP and cGMP requirements.
• Experience with analytical method validation, verification, or transfer.
• Knowledge of laboratory investigations, OOS/OOT investigations, and data integrity principles.
• Experience preparing and reviewing validation protocols and reports.
• Familiarity with laboratory instrumentation and analytical techniques.
• Strong technical writing, documentation, and recordkeeping skills.
• Ability to interpret analytical data, troubleshoot laboratory issues, and support corrective actions.
• Strong attention to detail and ability to work effectively in a regulated quality environment.
• Ability to collaborate with cross-functional teams and maintain compliance with safety, quality, and environmental procedures.

Preferred Qualifications

• Knowledge of SOPs, 21 CFR Part 11, and FDA regulatory expectations.
• Pharmaceutical manufacturing laboratory experience.
• Experience supporting equipment qualification activities.
• Experience with continuous improvement initiatives in an analytical laboratory environment.

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.