Quality Control Documentation Specialist

The Quality Control Documentation Specialist is responsible for performing the data review for the release of regulated and/or non-regulated materials including raw materials, in-process and finished products under general supervision and in accordance with standard operating procedures (SOPs). The incumbent will maintain the Quality Control document system, paper and electronic, including but not limited to: Laboratory notebooks, logbooks, controlled forms, and electronic data. They may also compile data and prepare reports for the purpose of trending or support for investigative purposes.ResponsibilitiesReview batch data for release of GMP/ISO and/or non-regulated materials by ensuring the product meets set standardsReview data, including raw data, laboratory notebooks, logbooks, and forms, for completeness and accuracy, including audit trails and electronic dataTrain on and follow documented procedures under GMP guidelinesCompile data for trending purposes (i.e. cycle times)Author or edit test procedures and SOPsSupport investigation team by compiling or reviewing related dataPrepare summary or trend reportsWrite deviation, CAPA reports, including root cause analysis and implementing appropriate corrective actionsTrack and maintain laboratory notebooks, logbooks, controlled forms, spreadsheets, training records, and other QC related documentsTrain others on practices of data review and documentationRequirementsBachelor's Degree in Chemistry or a similar scientific concentrationThree (3) or more years of technical experience with GC, GC/MS, ICP-MS, LC/MS, NMR or HPLC experience required. QC and GMP experience preferredHands-on experience with ELN or LIMS software strongly preferredPrevious experience with review or peer assessment of analytical dataMust be able to multi-task, take initiative, and follow through in a fast-paced environmentMust be able to work efficiently and independently under general supervisionMust work well in a team-oriented environment and possess strong interpersonal skills, including verbal and written communicationMust possess the ability to focus on streamlining workflows and providing solutions for continuous improvementMust be able to travel between sites (Tewksbury, MA and Andover, MA)Must be able to lift up to 50 lbs and utilize transport aidsMust be comfortable handling various chemicals and gases in a laboratory setting

Created: 2025-03-03