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.
location: Portsmouth, New Hampshire
job type: Contract
salary: $31 - 33 per hour
work hours: 9 to 5
education: Associate
responsibilities:
- 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
qualifications:
Required Qualifications
- Education: Associate's Degree in Microbiology, Biochemistry, or a related science field.
- Compliance: Proven experience working within a GMP pharmaceutical environment and applying Data Integrity principles.
- Software Proficiency: Hands-on experience with SoftmaxPro, Empower, or SoloVPE.
- Validation: Experience drafting GMP procedures, validation documents, and executing test scripts.
- Soft Skills: Strong cross-functional communication and ability to manage assigned training and evolving priorities.
- Subject Matter Expertise: Ability to serve as a SME for one or more core software systems.
- Technical Troubleshooting: Experience performing root-cause analysis for software-related errors.
skills: Microbiology, Laboratory Information Management Systems (LIMS), Good Manufacturing Practices (GMP)
Equal Opportunity Employer: Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.
At Randstad, we welcome people of all abilities and want to ensure that our hiring and interview process meets the needs of all applicants. If you require a reasonable accommodation to make your application or interview experience a great one, please contact HRsupport@randstadusa.com.
Pay offered to a successful candidate will be based on several factors including the candidate's education, work experience, work location, specific job duties, certifications, etc. In addition, Randstad offers a comprehensive benefits package, including: medical, prescription, dental, vision, AD&D, and life insurance offerings, short-term disability, and a 401K plan (all benefits are based on eligibility).
This posting is open for thirty (30) days.
