Senior Data Review Specialist

The Role

Applies GMP/GLP/ISO 17025 compliance standards in all areas of responsibility, as appropriate

Applies the highest quality standard in all areas of responsibility

Demonstrates and promotes the company vision

Demonstrates strong client service skills, teamwork, and collaboration

Proactively plans and multitasks to maximize productivity

Maintains high quality in meeting all quality and productivity metrics and demonstrates strong teamwork and collaboration

Regular attendance and punctuality

Communicate effectively with client, staff members, and management

Communicates (oral and written) effectively and shows attention to detail

Performs Data Review of routine data described from the following:

• Single and double analyte chromatography methods from GCMS, HVGC, and LC labs
• Multi-analyte chromatography methods from GCMS, HVGC, and LC labs
• Smoke data from HP, Vapor, Combustible, and FSC
• Inorganics lab, wet chemistry
• Microbiology lab, SPOT, Enumeration, Water Activity, Endotoxin, b-glucan

Perform Data Review of freeform notebooks and controlled forms using GDP

Use current versions of SOPs and work instructions to perform Data Review

Real-time documentation according to Good Documentation Practices

Assess analytical data for accuracy and compliance

Collaboration with QA and analysts to ensure proper documentation

Proficient in Microsoft Office including Excel, PowerPoint, Outlook

Complete Monthly reports regarding production, accomplishments, and difficulties

Complete all assigned training on time

Lead completion of Capacity metrics

Lead Hot Studies

Develop and edit Work Instructions and SOPs

Proficient in simple math including:

• Unit conversions
• Standard calculations
• Dilution factors
• Dilution schemes

Review of complex calculations on Microsoft Excel Spreadsheets

Proficient in LIMS

Proficient understanding of instrumentation used in the labs, including but not limited to:

• GC-FID/TCD
• GCMS
• LCMS, DAD, UV, RI, IC
• LC/MS/MS, GC/MS/MS
• TOF
• ICPMS, ICPOES
• Atomic Absorption
• pH
• KF- Karl Fisher

Requirements

• Bachelor’s degree in chemistry, biology, or other related degree concentration, or equivalent directly related experience (2 years of directly related industry experience is equivalent to 1 full-time year of college in a related major).
• Minimum of 4 years of experience in laboratory chromatography analyses, Quality, Regulatory, or related experience
• Experience in a cGMP and/or ISO 17025 environment
• Strong computer, scientific, and organizational skills
• Excellent communication (oral and written) and attention to detail
• Ability to work independently and as part of a team, self-motivation, adaptability, and a positive attitude
• Authorization to work in the United States indefinitely without restriction or sponsorship

Qualifications

• Bachelor’s degree in chemistry, biology, or other related degree concentration, or equivalent directly related experience (2 years of directly related industry experience is equivalent to 1 full-time year of college in a related major).
• Minimum of 4 years of experience in laboratory chromatography analyses, Quality, Regulatory, or related experience
• Experience in a cGMP and/or ISO 17025 environment
• Strong computer, scientific, and organizational skills
• Excellent communication (oral and written) and attention to detail
• Ability to work independently and as part of a team, self-motivation, adaptability, and a positive attitude
• Authorization to work in the United States indefinitely without restriction or sponsorship

Benefits

• Comprehensive medical coverage
• Dental coverage
• Vision coverage
• Life and disability insurance
• 401(k) with company match
• Paid vacation and holidays