SCN BestCo · 12 hours ago
Laboratory Data Specialist
Mooresville, NC
Full-time
Onsite
Senior Level
5+ years expSCN BestCo is a leading innovator in the Vitamin, Mineral & Supplement industry, dedicated to making health and wellness enjoyable. The Laboratory Data Specialist ensures the accuracy and compliance of analytical data in the Quality Control laboratories, supporting regulatory standards and enhancing data management processes.
HealthcareManufacturingPharmaceuticalMedical
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)
Qualification
Required
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
Preferred
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
Company
SCN BestCo
SCN BestCo develops and manufactures pharmaceutical dosage forms for the OTC drug, vitamin, and supplement marketplace.
1001-5000 employees
Funding
Current Stage
Late StageLeadership Team
Ashley Hernandez
Human Resources Business Partner
Bernd Thomas
Chief Supply Chain Officer
Recent News
2024-12-11
Asia Food Journal
2024-05-21
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