QC Specialist, Raw Materials

Canton, MA

Posted: 01/09/2023 Industry: Scientific Job Number: 23-00015

Job Description

I. JOB SUMMARY This is a laboratory support position with strong skills in laboratory testing and quality documentation. Major responsibilities being testing, material qualification, compendial method verification, and quality systems support. Works on complex and varied problems/projects requiring in depth analysis and interpretation .
II. ESSENTIAL FUNCTIONS Reasonable accommodations will be made to enable individuals with disabilities to perform the essential functions.

  • Sample, label, test, send for external testing, and release of incoming raw materials using LIMS.
  • Own and drive to completion:
    • quality notifications and tasks in the quality management system (deviations, CAPA, Change Controls, Effectiveness Checks)
    • creation of new documents and document updates
    • Performance of material qualification tasks (testing, report generation)
    • Completion of raw material risk assessments
    • laboratory invalid and out of specification investigations
    • Performance of compendial method verifications (testing, report generation)

Technical Expertise:
  • Has core understanding of applicable compliance/guidance/regulations (ISO, USP, FDA, EU).
  • Demonstrates proficiency in compendial raw material testing including moderately complex methods such as FTIR, Titration, UV Vis Spectrophotometry, Gel Electrophoresis, HPLC, and Loss on Drying.
  • Experience using LIMS to manage samples and document testing results.
  • Ability to Investigate and determine Root Cause associated with laboratory deviations.
  • Owns Change Controls, CAPAs, and Effectiveness Checks
  • Maintains laboratory equipment as per established procedure

Laboratory Support (Including Quality Systems):
  • Performs as supporting personnel and/or acts as lead under guidance of management or higher-level scientific personnel.
  • Provide guidance to lower level personnel.
  • May perform scheduling to ensure critical QC metrics are consistently met for product turnaround times.
Quality Systems:
  • Reviews and Verifies QC data.
  • Author/revise and contributes test methods; SOPs; specifications; protocols, technical studies or reports.
  • Author laboratory investigations and non-conformance.
  • Owns CAPA and change control with leading project planning and collaboration.

Problem Solving:
  • Works on problems of diverse scope requiring evaluation of identifiable factors.
  • Exercises judgment within defined procedures and practices to determine appropriate action.
  • Receives no instruction on routine work, general instructions on new assignments.

Behavior/Cultural Responsibilities:
  • Ownership Actively participate in self-development
  • Accountability Follow through on commitments, Situational Leadership or additional accountability tools
  • Detail oriented Able to complete required tasks and associated documentation with minimal error
  • Adaptability Maintain positive attitude in a changing work environment
  • Communication Effectively communicate with all levels of manufacturing and support staff
  • Actively participate in department / level meetings
  • Escalate issues through the proper channels
  • Live the Core Values

The above statements are intended to describe the nature of work performed by those in this job and are not an exhaustive list of all duties. Nothing in this job description restricts managements right to assign or reassign duties and responsibilities to this job at any time which reflects management's assignment of essential functions.
  • Bachelor's or master's degree in an applied science (chemistry preferred).
  • 5+ years of experience preferred, or equivalent level of skill and experience.
  • Previous hands-on experience with Raw Material assays in a GMP manufacturing environment is preferred.
  • Personal Competencies: self-awareness, integrity, team player, innovative, and flexible.
  • An understanding of cGMP, CFR, and USP is required.
  • Require good written and verbal communication skills, good teamwork skills
  • Computer skills (MS Office, MS Excel, MS Project) or comparable word-processing and spreadsheet applications is required.
Type/keyboard, visual acuity, good hand/eye coordination, stand, walk, sit, twist/turn, climb, reach outward, reach above shoulder, hand dexterity, bend, squat/kneel, sense of feel, sense of hearing, sense of smell, lift/carry 50 lbs, and pull 50 lbs. Use phone, fax, copier and computer. Organize/coordinate, analyze/interpret, calibrate precise measurements, problem solve, make decisions, plan, communicate, prepare written communications and prepare transaction documents.

Physical/Mental Demands and Work Environment Characteristics :

Mental Demands:
Ability to organize/coordinate Comprehend and follow instructions

Direct, control and plan Independently make quick decisions to solve complex issues

Problem Solve Analyze/Interpret data and information

Perform with frequent interruptions Make decisions using sound judgment

Supervise/Manage others

Physical Demands:
Good eye/hand coordination Visual Acuity

Use keyboard/computer/phone Detect/Distinguish smell

Detect/Distinguish hearing Maintain stationary position

Position self to move Move/Traverse

Ascend/Descend (climb) Reaching

Calibrate precise Ability to safely operate hand tools

Move/Transport [50] lb. Repetitive movement activities

Environmental Characteristics:

Regular and predictable attendance

Work around extreme temperatures cold or hot

Work around noise above conversation level

Work in restricted access to laboratory area

Exposure to dust/gas/fumes/steam/chemicals

Work with Select Agents as defined by the CDC

Work irregular hours that often include nights and weekends

Work in multiple locations


Kaztronix is an equal opportunity employer and does not discriminate on the basis of race, color, national origin, sex, age, religion, disability, veteran status or any other consideration made unlawful by federal, state or local laws. In addition, all human resource actions in such areas as compensation, employee benefits, transfers, layoffs, training and development are to be administered objectively, without regard to race, color, religion, age, sex, national origin, disability, veteran status or any other consideration made unlawful by federal, state or local laws.

By applying to the position, you acknowledge that your information will be used by Kaztronix in processing your application.

Meet Your Recruiter

Clarence Alphonso

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