Lab Investigator

Accupac; Mainland (PA); On-site; USD 70,000 - 75,000; Full time

Job summary

Accupac in Mainland, PA is seeking a Lab Investigator to support Quality Systems with investigations, data review, and regulatory documentation.

The role requires a B.S. in Analytical Chemistry with 5+ years in a pharmaceutical-quality environment, LIMS/DMS experience, and strong analytical/problem-solving skills.

Qualifications

• Bachelor’s degree in Analytical Chemistry or Chemistry with 5+ years in quality roles in a regulated setting.
• Experience in laboratory investigations (LIR/NIR) is highly desirable.
• Proficient with DMS and LIMS; comfortable with regulatory documentation.

Responsibilities

• Participate in analytical investigations and non-conformance investigations.
• Gather and analyze data from Lab Services; review in LIMS.
• Prepare investigation reports and ensure timely closure of CAPAs.

Skills

Investigative skills

English communication

MS Office

DMS/LIMS experience

Total Chrom/Open Lab

cGMP compliance

Analytical problem-solving

Education

Bachelor's of Science in Analytical Chemistry

Tools

Total Chrom

Open Lab

Job description

Job Title Lab Investigator

Job ID 27787569 Location Mainland, PA Other Location Description

Salary

$70K-$75K + Gainsharing Bonus

Address of role

1501 Industrial Blvd, Mainland, PA 19451

Basic Job Functions

Provide support to Quality Systems (review SOPs, protocols, reports, data, records generated and other quality-related documents) for the manufacturing and distribution of product.

Essential Functions Of The Job

• Participate in analytical laboratory investigations (LIR) and other non-conformance investigations (NIR)
• Gather and analyze critical data from Lab Services (raw data, chromatography, calculations, data trend study) and review in LIMS
• Review Test methods and Laboratory notebooks for accuracy
• Analyze instrument performance, column age, previous failures
• Gather critical data and enter onto spreadsheets
• Conduct personnel interviews and system reviews
• Observe analytical testing for investigations
• Prepare investigation reports and oversee applicable approvals
• Compile data/documentation from Manufacturing, Packaging, and/or Laboratories
• Determine conclusions, prepare investigation reports and assign relative CAPAs
• Summarize and complete the LIR with a scientific assignable root cause and update the LIR spread sheets in a timely manner
• Communicate effectively with customers, project managers and Lab Management
• Assure timely closure of LIRs, CAPAs, assist in performing effectiveness checks
• Review records to ensure data meets the industry requirements for data integrity - resolve any discrepancies
• Ensure procedures are followed as outlined per FDA, ICH, Standard Methods, SOP and the Quality Systems’ requirements
• Support Management with audits.
• Perform other quality-related duties as assigned.
• Maintain and Publish Monthly metrics on Laboratory investigation

Minimum Requirements Of The Job

• Excellent Investigative skills such as analytical problem solving, fish bone, and root cause analysis, etc. Prior experience in Laboratory investigation is a plus.
• Ability to read, write, understand and communicate in English. Prior experience in technical writing is preferred.
• Proficient computer skills and typing
• Comfortable with working in an analytical testing laboratory atmosphere and proficient with common laboratory equipment/instrumentation, tools, reagents, etc.
• Effective analytical and problem-solving skills. Must be able to clearly communicate technical, scientific, and regulatory information, both written and verbally
• Clear understanding of analytical testing. Familiarity of USP/EP/FCC test methods is a must
• Experience in a pharmaceutical and regulated environment
• Must have experience with Digital Documentation Management System (DMS) and LIMS
• Knowledge in operating Total Chrom and Open Lab software is desired.
• Comply with all company policies, SOPs, cGMP and relevant industry, regulatory and safety requirements
• Maintain internal training at or above 95% of assigned curriculum
• Demonstrate Good Documentation Practices
• Working knowledge of MS Office applications (Word, Excel, etc…)
• Performs all tasks with integrity. Candidate must be meticulous and organized.
• Ability to be flexible with changing priorities in a dynamic environment.
• Ability to work independently, as well as in a team, to meet deadlines as assigned.
• Candidate will be cross-trained in other Quality System functions as needed

Physical Requirements

• Good eye sight (with correction) and hearing (ability to hear alarms, ringing).
• Frequent contact with chemicals used for testing in the analytical laboratory.
• Walking/Standing/Sitting for longer periods of time
• Bending/stooping.
• Lift/carry items up to 30 pounds.
• Pushing/pulling items up to 25 pounds.
• Good eye sight (with correction) and hearing (ability to hear alarms, ringing).

Supervisory Responsibilities

No

Travel

None

Education/Experience

Quality Systems Associate/Lead Investigator-Lab Services must have earned a Bachelors of Science degree (Analytical Chemistry/Chemistry courses required), and 5+ years of Quality experience in a related field with at least a few years of hands‑on lab experience.

#INDOTHER2026

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Required Skills

• Excellent Investigative skills such as analytical problem solving, fish bone, and root cause analysis, etc. Prior experience in Laboratory investigation is a plus.
• Ability to read, write, understand and communicate in English. Prior experience in technical writing is preferred.
• Proficient computer skills and typing
• Comfortable with working in an analytical testing laboratory atmosphere and proficient with common laboratory equipment/instrumentation, tools, reagents, etc.
• Effective analytical and problem-solving skills. Must be able to clearly communicate technical, scientific, and regulatory information, both written and verbally
• Clear understanding of analytical testing. Familiarity of USP/EP/FCC test methods is a must
• Experience in a pharmaceutical and regulated environment
• Must have experience with Digital Documentation Management System (DMS) and LIMS
• Knowledge in operating Total Chrom and Open Lab software is desired.
• Comply with all company policies, SOPs, cGMP and relevant industry, regulatory and safety requirements
• Maintain internal training at or above 95% of assigned curriculum
• Demonstrate Good Documentation Practices
• Working knowledge of MS Office applications (Word, Excel, etc…)
• Performs all tasks with integrity. Candidate must be meticulous and organized.
• Ability to be flexible with changing priorities in a dynamic environment.
• Ability to work independently, as well as in a team, to meet deadlines as assigned.
• Candidate will be cross-trained in other Quality System functions as needed