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This role requires employees to be fully vaccinated against COVID-19 as a condition of employment, subject to a valid medical or religious accommodation.
location: Swiftwater, Pennsylvania
job type: Contract
salary: $25.00 - 30.73 per hour
work hours: 9 to 5
The FSL/Validation Specialist will be responsible:
- Perform aseptic validation sampling and data analysis of the results
- Ensure proper execution and GMP Documentation of test results, and compilation of validation packages.
- Retrieve and compile data from electronic sources / databases and paper records
- Responsible for authoring, reviewing, executing and approving validation documents written within an electronic data management system. Execution of Validation Protocols.
- Assist in writing and revising Standard Work Instructions , Standard Operating Procedures, and Batch Production Records
3-10 years. Experience in working in a Pilot Plant and/or cGMP manufacturing environment. Sample coordination and execution of Validation Protocols are preferred.
MS Office 2010 MS Word, Excel, PowerPoint and Outlook
EDoc with a working knowledge of templates, workflows and approval process
Utilize cGMP skills and methods either in a manufacturing or Pilot Plant environment
Good lab / aseptic technique
Knowledge of current GMP Standards
Experience in LIMS preferred
Full understanding of GMP Documentation
Flexibility of hours during execution to include nights and weekends
Cleaning validation execution preferred. Experience with Manual and Automated Cleaning Systems
Technical writing abilities and time management skills.
Root cause analysis skills with cGMP experience.
To be able to establish professional working relationships with other support and production areas in order to gather all of the necessary information required.
Interact well and professionally with a diverse group of individuals.
Self-motivated and willing to be proactive in resolving issues
Excellent Verbal and written communication skills.
Ability to work in a team environment
Ability to write and complete deviations in a timely and thorough manner
Ability to multitask and prioritize tasks
BS/MS in Engineering, Life Science or Physical Science
skills: MS-WORD, MS-EXCEL, Laboratory Information Management Systems (LIMS), GMP (Good Manufacturing Practice)
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 health, an incentive and recognition program, and 401K contribution (all benefits are based on eligibility).
For certain assignments, Covid-19 vaccination and/or testing may be required by Randstad's client or applicable federal mandate, subject to approved medical or religious accommodations. Carefully review the job posting for details on vaccine/testing requirements or ask your Randstad representative for more information.