GMP Analytical Scientist – Pharma, Data Integrity

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

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,