Sr. Process Development Associate
Spectraforce
Thousand Oaks, California
2 days ago
Job Description
Job Title: Sr. Process Development Associate
Duration: 12+ Months (Potential Extension)
Location: Thousand Oaks, CA 91320
The ideal candidate for the Process Development Senior Associate role is a detail-oriented laboratory professional with hands-on experience supporting analytical workflows in a pharmaceutical, biopharmaceutical, or comparable laboratory environment. This individual has working knowledge of Empower and/or Chromeleon software used to control HPLC and related analytical instruments, demonstrates strong Good Documentation Practices (GDP), and communicates clearly with cross-functional teams. A bachelor’s degree in chemistry, biochemistry, or a related scientific discipline is required, while years of experience are flexible as comprehensive training will be provided. Candidates must be comfortable working on-site in a GMP setting, supporting data verification activities, and contributing reliably throughout a one-year project engagement.
Data Verifier – BioVia Notebook, Empower, and Chromeleon Data (Regulatory Filing Support)
Overview
We are seeking a detail-oriented and highly disciplined Senior Associate to perform data verification for a Rapid Analytics Lab located at Thousand Oaks California. This role will focus on verifying Notebook entries, Empower chromatographic data, and Chromeleon instrument data to confirm alignment with reporting requirements and Good Documentation Practices (GDP). The ideal candidate possesses strong analytical expertise, exceptional diligence, and a deep understanding of expectations for data review.
Key Responsibilities
• Perform comprehensive verification of analytical data packages, including Notebook records, Empower chromatographic results, and Chromeleon sequences and reports.
• Confirm data accuracy, traceability, and compliance with internal SOPs and regulatory expectations (e.g., FDA, EMA, ICH).
• Ensure that data used in regulatory filings are complete, consistent, and appropriately linked to source systems.
• Identify discrepancies or omissions in data packages and work collaboratively with laboratory analysts and technical leads to resolve issues.
• Verify metadata, audit trails, instrument parameters, and processing methods to ensure appropriate data governance and ALCOA+ principles.
• Participate in process improvement initiatives related to data verification workflows and digital system integration.
• Maintain organized, inspection-ready documentation to support internal audits and health authority inspections.
Basic Qualifications
• Bachelor’s degree in a scientific discipline (e.g., Chemistry, Biochemistry, Biotechnology, Analytical Sciences) or equivalent combination of education and relevant experience.
• Experience working with laboratory information systems, including Empower and/or Chromeleon, and electronic Laboratory Notebook systems (ELN/LIMS).
• Strong understanding of chromatographic techniques (Capillary Electrophoresis/HPLC/UPLC), data processing, and instrument workflows.
• Demonstrated familiarity with data integrity principles
Preferred Qualifications
• 2+ years of experience in data verification and analytical laboratory operations.
• Minimum: Bachelor’s degree
• Direct experience in preparing or supporting data for regulatory filings.
• Knowledge of analytical method validation, transfer, release, and stability testing.
• Ability to clearly communicate data issues, trends, and resolutions to cross-functional teams.
• High aptitude for working with digital systems, data governance tools, and structured documentation.
Key Competencies
• Exceptional attention to detail and accuracy
• Strong organizational and prioritization skills
• Ability to work independently while collaborating effectively with analysts, SMEs, and regulatory teams
• Professional communication and documentation skills
• Commitment to data integrity and continuous improvement
Basic Qualifications:
Master’s degree
OR
Bachelor’s degree and 2 years of Process Development experience
OR
Associate’s degree and 4 years of Process Development experience
OR
High school diploma / GED and 6 years of Process Development experience
Top 3 Must Have Skill Sets:
- Knowledge of Empower and Chromeleon software
- Knowledge of Good Documentation Practices
- Electronic notebook such as BioVia Electronic Notebooks or other electronic notebook systems
Additional note on must haves:
• Bachelors in: Chemistry, Biochemistry, or related scientific discipline
• Working knowledge of Empower and/or Chromeleon software
o Used to control and manage HPLC and related analytical instruments
o Industry-standard systems (not Amgen-specific)
• Experience with HPLC and related analytical techniques
• Strong understanding of Good Documentation Practices (GDP)
• High attention to detail, accuracy and data integrity are critical
• Ability to communicate clearly with multiple analysts and stakeholders
Day to Day Responsibilities:
• Perform comprehensive verification of analytical data packages, including Notebook records, Empower chromatographic results, and Chromeleon sequences and reports.
• Confirm data accuracy, traceability, and compliance with internal SOPs and regulatory expectations
• Ensure that data used in regulatory filings are complete, consistent, and appropriately linked to source systems.
• Identify discrepancies or omissions in data packages and work collaboratively with laboratory analysts and technical leads to resolve issues.
• Verify metadata, audit trails, instrument parameters, and processing methods to ensure appropriate data governance and ALCOA+ principles.
• Participate in process improvement initiatives related to data verification workflows and digital system integration.
• Maintain organized, inspection-ready documentation to support internal audits and health authority inspections.
At SPECTRAFORCE, we are committed to maintaining a workplace that ensures fair compensation and wage transparency in adherence with all applicable state and local laws. This position’s starting pay is: $ 35.00/hr.
Duration: 12+ Months (Potential Extension)
Location: Thousand Oaks, CA 91320
The ideal candidate for the Process Development Senior Associate role is a detail-oriented laboratory professional with hands-on experience supporting analytical workflows in a pharmaceutical, biopharmaceutical, or comparable laboratory environment. This individual has working knowledge of Empower and/or Chromeleon software used to control HPLC and related analytical instruments, demonstrates strong Good Documentation Practices (GDP), and communicates clearly with cross-functional teams. A bachelor’s degree in chemistry, biochemistry, or a related scientific discipline is required, while years of experience are flexible as comprehensive training will be provided. Candidates must be comfortable working on-site in a GMP setting, supporting data verification activities, and contributing reliably throughout a one-year project engagement.
Data Verifier – BioVia Notebook, Empower, and Chromeleon Data (Regulatory Filing Support)
Overview
We are seeking a detail-oriented and highly disciplined Senior Associate to perform data verification for a Rapid Analytics Lab located at Thousand Oaks California. This role will focus on verifying Notebook entries, Empower chromatographic data, and Chromeleon instrument data to confirm alignment with reporting requirements and Good Documentation Practices (GDP). The ideal candidate possesses strong analytical expertise, exceptional diligence, and a deep understanding of expectations for data review.
Key Responsibilities
• Perform comprehensive verification of analytical data packages, including Notebook records, Empower chromatographic results, and Chromeleon sequences and reports.
• Confirm data accuracy, traceability, and compliance with internal SOPs and regulatory expectations (e.g., FDA, EMA, ICH).
• Ensure that data used in regulatory filings are complete, consistent, and appropriately linked to source systems.
• Identify discrepancies or omissions in data packages and work collaboratively with laboratory analysts and technical leads to resolve issues.
• Verify metadata, audit trails, instrument parameters, and processing methods to ensure appropriate data governance and ALCOA+ principles.
• Participate in process improvement initiatives related to data verification workflows and digital system integration.
• Maintain organized, inspection-ready documentation to support internal audits and health authority inspections.
Basic Qualifications
• Bachelor’s degree in a scientific discipline (e.g., Chemistry, Biochemistry, Biotechnology, Analytical Sciences) or equivalent combination of education and relevant experience.
• Experience working with laboratory information systems, including Empower and/or Chromeleon, and electronic Laboratory Notebook systems (ELN/LIMS).
• Strong understanding of chromatographic techniques (Capillary Electrophoresis/HPLC/UPLC), data processing, and instrument workflows.
• Demonstrated familiarity with data integrity principles
Preferred Qualifications
• 2+ years of experience in data verification and analytical laboratory operations.
• Minimum: Bachelor’s degree
• Direct experience in preparing or supporting data for regulatory filings.
• Knowledge of analytical method validation, transfer, release, and stability testing.
• Ability to clearly communicate data issues, trends, and resolutions to cross-functional teams.
• High aptitude for working with digital systems, data governance tools, and structured documentation.
Key Competencies
• Exceptional attention to detail and accuracy
• Strong organizational and prioritization skills
• Ability to work independently while collaborating effectively with analysts, SMEs, and regulatory teams
• Professional communication and documentation skills
• Commitment to data integrity and continuous improvement
Basic Qualifications:
Master’s degree
OR
Bachelor’s degree and 2 years of Process Development experience
OR
Associate’s degree and 4 years of Process Development experience
OR
High school diploma / GED and 6 years of Process Development experience
Top 3 Must Have Skill Sets:
- Knowledge of Empower and Chromeleon software
- Knowledge of Good Documentation Practices
- Electronic notebook such as BioVia Electronic Notebooks or other electronic notebook systems
Additional note on must haves:
• Bachelors in: Chemistry, Biochemistry, or related scientific discipline
• Working knowledge of Empower and/or Chromeleon software
o Used to control and manage HPLC and related analytical instruments
o Industry-standard systems (not Amgen-specific)
• Experience with HPLC and related analytical techniques
• Strong understanding of Good Documentation Practices (GDP)
• High attention to detail, accuracy and data integrity are critical
• Ability to communicate clearly with multiple analysts and stakeholders
Day to Day Responsibilities:
• Perform comprehensive verification of analytical data packages, including Notebook records, Empower chromatographic results, and Chromeleon sequences and reports.
• Confirm data accuracy, traceability, and compliance with internal SOPs and regulatory expectations
• Ensure that data used in regulatory filings are complete, consistent, and appropriately linked to source systems.
• Identify discrepancies or omissions in data packages and work collaboratively with laboratory analysts and technical leads to resolve issues.
• Verify metadata, audit trails, instrument parameters, and processing methods to ensure appropriate data governance and ALCOA+ principles.
• Participate in process improvement initiatives related to data verification workflows and digital system integration.
• Maintain organized, inspection-ready documentation to support internal audits and health authority inspections.
Applicant Notices & Disclaimers
- For information on benefits, equal opportunity employment, and location-specific applicant notices, click here
At SPECTRAFORCE, we are committed to maintaining a workplace that ensures fair compensation and wage transparency in adherence with all applicable state and local laws. This position’s starting pay is: $ 35.00/hr.