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location: Lexington, Massachusetts
job type: Contract
salary: $61.01 - 71.78 per hour
work hours: 9 to 5
- Expertise and technical leadership managing product testing, method validations/transfer, investigations, CAPAs, change requests, and deviations.
- Manage assay transfer and/or validation activities for QC, including authoring and/or reviewing protocols, coordinating testing with CTLs, performing statistical data analysis and final summary reports per ICH and company internal guidelines.
- Lead investigator providing technical and analytical representation for QC on investigation teams, with strong understanding of compliance and cGMP's, strong scientific judgment and leadership in decision making.
- Coordinate analytical support within QC necessary to identify root cause.
- Facilitate investigations, review of process and method validation initiatives in support of the QC laboratories in the resolution of OOS investigations.
- Provide technical expertise and support for troubleshooting and assay remediation.
- Manage and contribute to cross functional teams to close investigations, determination of root cause, and implementation of appropriate CAPAs.
- Lead management of the document change requests for method SOPs.
- Works on problems of diverse scope in which analysis of situation or data requires evaluation of identifiable factors.
- Exercises judgment within generally defined practices and policies in selecting methods and techniques for obtaining solutions.
- Technical Program/project Management (35%)
- Technical writing-author and review of protocols, reports, data summaries, procedures, LIMS etc. (25%)
- Support investigations of product deviations (25%)
- Work with QC, QA, Supply Chain, Analytical Development, Process Development, Manufacturing, Technical Services, Regulatory Affairs, CTLs and CMOs (15%)
- Degree in Chemistry or Biological sciences.
- 7-10 years' experience in pharmaceutical industries
- Experience with analytical method validation, product testing and/or GMP investigations
- Direct experience within GMP organizations, experience in Quality preferred
- Excellent, professional interpersonal and communication skills (both verbal and written)
- Demonstrated ability to work effective by independently and on cross functional teams
skills: Project Management, Quality control, SOP, CAPA, Laboratory Information Management Systems (LIMS), ICH Regulations, 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.