Sign upLog in

QC Specialist II

Lenmar Consulting, Inc.

Portsmouth, NH

Apply
JOB DETAILS
SKILLS
Analysis Skills, Assays, Biochemistry, Biotech and Pharmaceutical, Change Control, Communication Skills, Computer Systems, Corporate Policies, Corrective and Preventative Action (CAPA) Systems, Cross-Functional, Data Analysis, Data Quality, Establish Priorities, GMP (Good Manufacturing Practices), Laboratory Information Management System (LIMS), Microbiology, Microsoft Excel, Microsoft PowerPoint, Microsoft Product Family, Microsoft Word, Problem Solving Skills, Procedure Development, Product Testing, Production Support, Quality Assurance Methodology, Quality Control, Root Cause Analysis, Software Validation, Team Player, Test Scripts, Testing, Time Management, Validation Documentation
LOCATION
Portsmouth, NH
POSTED
30+ days ago
The Quality Control Technical Transfer Analyst (QC Specialist) will act as a team member of the Quality Control department to support production by contributing to the completion of the technical transfer activities. Also participate in quality testing for customer in-process, final product testing and stability studies when needed.

Applies job skills and company's policies and procedures to complete a variety of tasks of increased scope. Works on assignments that are semi-routine in nature where ability to recognize deviation from accepted practice is required. Works on problems of moderate scope in which analysis of situation or data requires a review of identifiable factors.
  • Applies job skills and company's policies and procedures to complete a variety of tasks.
  • Running test samples for In-Process, Lot Release and Stability studies.
  • Running test samples for (but not limited to) investigations, transfers and validations.
  • Reviewing assays
  • Training others
  • Has experience with: Change Control, Deviations, CAPAs, Tasks, EICRs, Investigations.
  • Writing- Quality Records (Deviations, CAPA, Change Control) and Test Methods
  • Projects – such as method transfers, new instruments, method qualifications
  • Use of Microsoft Suites (Word, Excel, PowerPoint)
  • Use of Laboratory computer systems
  • Potential previous use of GMP Quality Systems such as: TrackWise, LIMS
  • Works on assignments that are semi-routine in nature where ability to recognize deviation from accepted practice is required.
  • Works on problems of moderate scope in which analysis of situation or data requires a review of identifiable factors.
  • Apply Data Integrity principles in all aspects of work, in compliance with *** DI policies, guidelines and procedures.
  • Perform other duties as assigned.
  • Strong ability to speak publicly.
  • Strong ability to interpret data both alone and with guidance.
  • Perform assigned, complex and/or varied tasks.
  • Prioritization and problem solving.
  • Comprehend and follow instructions.
  • Direct, control and plan tasks/projects.
  • Brainstorming
  • Strong ability to communicate in both written and verbal format .
  • Exercises judgment within defined procedures and practices to determine appropriate action.
  • Self-motivated team player
  • Completes assignments on-time and accurately
  • Displays commitment to quality and performs job functions to the best of his/her ability
  • Relate to others in a team setting.
  • Maintain positive attitude in a team environment.
  • Timeliness in completing assigned tasks.
  • Works entire assigned shift, including arriving on time
  • Has experience with or currently uses the following software:
  • SoftmaxPro, Empower, SoloVPE
  • Has experience with software validations including but not limited to: writing GMP procedures and validation documents and executing test scripts.
  • Acts as a SME for at least one software system
  • Communicates with cross functional teams to interpret needs and priorities.
  • Has GMP experience within the pharmaceutical industry
  • Can perform technical, root-cause analysis for some software errors
  • Applies Data Integrity principles in all aspects of work, in compliance with *** DI policies, guidelines and procedures.
  • Remains up to date on all assigned training activities.
  • Performs other duties as assigned.
Preferred - Bachelor's of Master's Degree in Microbiology, Biochemistry or Related Science Fields

About the Company

L

Lenmar Consulting, Inc.