Lab Investigator

Accupac•Mainland, PA

20d•Onsite

About The Position

The Lab Investigator provides support to Quality Systems for the manufacturing and distribution of products by reviewing SOPs, protocols, reports, data, records, and other quality-related documents. The role conducts laboratory and non-conformance investigations, analyzes laboratory data, prepares investigation reports, identifies root causes, and supports corrective and preventive actions (CAPAs). The position also helps maintain compliance with data-integrity expectations and applicable regulatory, quality, and safety requirements, and supports audits and monthly laboratory-investigation metrics.

Requirements

Bachelor of Science degree with Analytical Chemistry/Chemistry coursework.
At least 5 years of Quality experience in a related field, including a few years of hands-on laboratory experience.
Excellent investigative skills, including analytical problem-solving, fishbone analysis, and root-cause analysis.
Ability to read, write, understand, and communicate in English.
Proficient computer skills and typing.
Comfort working in an analytical testing laboratory and proficiency with common laboratory equipment, instrumentation, tools, and reagents.
Effective analytical and problem-solving skills.
Ability to communicate technical, scientific, and regulatory information clearly, both verbally and in writing.
Clear understanding of analytical testing.
Familiarity with USP/EP/FCC test methods.
Experience in a pharmaceutical and regulated environment.
Experience with a Digital Documentation Management System (DMS) and LIMS.
Working knowledge of MS Office applications, including Word and Excel.
Meticulous and organized, with flexibility to handle changing priorities in a dynamic environment.
Ability to work independently and collaboratively to meet assigned deadlines.
Ability to meet the stated physical requirements, including lifting/carrying items up to 30 pounds and pushing/pulling items up to 25 pounds.

Nice To Haves

Prior experience in laboratory investigations.
Prior experience in technical writing.
Knowledge of Total Chrom and Open Lab software.

Responsibilities

Participate in analytical laboratory investigations (LIRs) and other non-conformance investigations (NIRs).
Gather and analyze critical Lab Services data, including raw data, chromatography, calculations, and trend studies, and review information in LIMS.
Review test methods and laboratory notebooks for accuracy.
Analyze instrument performance, column age, and previous failures.
Gather critical data and enter it into spreadsheets.
Conduct personnel interviews and system reviews.
Observe analytical testing as part of investigations.
Prepare investigation reports and oversee applicable approvals.
Compile data and documentation from Manufacturing, Packaging, and/or Laboratories.
Determine conclusions, prepare investigation reports, and assign applicable CAPAs.
Summarize and complete LIRs with a scientific, assignable root cause and update LIR spreadsheets in a timely manner.
Communicate with customers, project managers, and Lab Management.
Ensure timely closure of LIRs and CAPAs, and assist with effectiveness checks.
Review records for compliance with industry data-integrity requirements and resolve discrepancies.
Ensure procedures are followed in accordance with FDA, ICH, Standard Methods, SOPs, and Quality Systems requirements.
Support Management with audits.
Maintain and publish monthly laboratory-investigation metrics.
Perform other quality-related duties as assigned.
Comply with company policies, SOPs, cGMP, and relevant industry, regulatory, and safety requirements.
Maintain internal training at or above 95% of the assigned curriculum and demonstrate Good Documentation Practices.
Perform assigned tasks with integrity, organization, and attention to detail; work independently or as part of a team to meet deadlines.
Cross-train in other Quality System functions as needed.