QC Specialist II
Sunrise Systems
Job Title: QC Specialist II
Job ID: 26-01177
Location: Portsmouth, NH 03801
Duration: 12 months
100% On site Position Summary:
Sunny Rajput | View email address on click.appcast.io | URL:
Job ID: 26-01177
Location: Portsmouth, NH 03801
Duration: 12 months
100% On site Position Summary:
- The Quality Control Technical Transfer Analyst 3 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 Lonza 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 Lonza DI policies, guidelines and procedures.
- Remains up to date on all assigned training activities.
- Performs other duties as assigned.
- Associate's Degree in Microbiology, Biochemistry or Related Science Fields
Sunny Rajput | View email address on click.appcast.io | URL:
Vacancy posted 4 days ago
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