Laboratory Data Specialist (1st Shift)

SCN BestCo•Mooresville, NC

12d

About The Position

The Laboratory Data Specialist plays a pivotal role in ensuring the accuracy, integrity, and compliance of analytical data generated within the Quality Control (QC) or Analytical Development laboratories. This role supports Good Laboratory Practices (GLP), Good Manufacturing Practices (GMP), and data integrity regulations. Responsibilities include providing subject matter expertise during internal and external audits and ensuring data integrity. This position proposes enhancements and explores innovative solutions to streamline workflows and elevate data management, analysis, and reporting. Mentorship is also part of this role, sharing best practices and fostering a culture of excellence. Cross-functional collaboration skills are regularly leveraged to work closely with research & development (R&D), QC laboratory, production, and regulatory teams. The Laboratory Data Specialist aligns data practices across departments, provides insights that support decision-making, and troubleshoots data-related challenges.

Requirements

Bachelor’s degree in chemistry or related scientific field.
5 years’ bench experience in a QC analytical laboratory or commensurate combination of higher education and relevant work experience in pharmaceuticals or closely related industry.
Strong understanding of cGMP, GLP, and laboratory compliance.
Strong technical writing skills and the ability to create technical documentation.
Ability to interpret and apply Good Manufacturing Practice (GMP) regulations.
Proficient in Microsoft Office including Excel and Word.
Familiarity with LIMS (Laboratory Information Management System).
Knowledge of statistical analysis and data trending.
Deep understanding of instrumental analysis and chemical analysis concepts
Excellent communication skills and attention to detail.
Ability to work independently and as part of a team.
Experience with HPLC, GC, dissolution testing, and other analytical techniques.
Strong analytical, decision-making, technical, organizational, planning, and written communication skills.
Ability to calculate figures and amounts such as, proportions, percentages, area, circumference, and volume. Ability to apply concepts of basic algebra and geometry.
Ability to read and interpret documents such as safety rules, operating and maintenance instructions, and procedure manuals. Ability to write routine reports and correspondence. Ability to speak effectively before groups of customers or employees of an organization.
Ability to apply common sense understanding to carry out instructions furnished in written, oral, or diagram form. Ability to deal with problems involving several concrete variables in standardized situations.

Nice To Haves

Experience with OpenLabs Chromatographic Software.
Deep understanding of good documentation practices and data integrity (FDA and cGMP).
Experience with Master Control or comparable Quality Management Software.
Product specification writing or management.
Experience with analytical methods and validation.
Experience with raw material and finished product specification set up.

Responsibilities

Review raw data, test results, and documentation generated during analytical testing.
Verify that data entries are complete, accurate, and comply with established procedures.
Cross-check calculations, sample IDs, and instrument parameters.
Identify any inconsistencies or deviations from expected patterns.
Ensure the integrity of computerized data in laboratory instrumentation and systems.
Ensure adherence to regulatory guidelines (e.g., FDA, ICH, USP, etc.) and internal quality standards.
Review laboratory notebooks, logbooks, and electronic records.
Document findings, observations, and corrective actions.
Collaborate with laboratory personnel to address data discrepancies promptly.
Participate in out-of-specification (OOS) result investigations, unexpected trends, and data anomalies.
Work closely with analysts and supervisors to resolve issues.
Participate in root cause analysis (RCA) and corrective/preventive action (CAPA) processes.
Prepare data for internal and external audits and assist in audit responses.
Maintain an organized and accessible data repository.
Propose and implement process enhancements to improve data quality, efficiency, and productivity.
Collaborate with cross-functional teams to implement best practices.
Stay informed about industry trends and technological advancements.
Provide leadership and guidance to junior data specialists and lab as needed.
Conduct review, revision updates, and drafting of standard operating procedures (SOP) for the QC analytical chemistry laboratory.
Release raw materials, packaging, in-process products, and finished products.
Train chemists in data integrity and good documentation practices.
Assist with the execution and management of product stability program.
Work collaboratively with cross-function teams to create, review and/or revise specifications for raw materials and finished products (in-process, release, stability).