Manufacturing Support Technologist - United States
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- The Manufacturing Support Technologist is responsible for managing product life-cycle of key products to include investigations, analysis, recommendations and implementation of product improvements.
- Specific tasks include: performing statistical data analysis of manufacturing process and QC data.
- Hands on activities in product improvement and development processes.
Essential Duties & Responsibilities:
- Perform product improvement and development activities to include pilot study setup, test studies, scale up manufacturing and product transfers.
- Perform statistical analysis for manufactured products, in-processes testing and final QC testing.
- Perform product support testing to supplement internal and external driven investigations.
- Work with QC Technologist to maintain and perform stability testing programs according to schedule.
- Perform QC and manufacturing document reviews.
- Develop validation documents (IQ,OQ,PQ) and perform validation as needed.
- Manage change control activities following design control guidelines.
- Work with RAQA and customers to address customer complaints and technical enquirers.
- Designated trainer and backup resource for QC testing and manufacturing.
- Knowledge of Spreadsheet software and Word Processing software.
- Ability to read and comprehend simple instructions, short correspondence, and memos. Ability to write simple correspondence.
- Ability to effectively present information in one-on-one and small group situations to customers, clients, and other employees of the organization.
- Understanding of Design Control and New Product Development Activities.
- Full understanding of equipment and product validation process.
Education and/or Experience:
- Bachelor's degree (B.S) from four-year college or university preferred; and two to three years related experience and/or training in biotech company.
- MT (ASCP) preferred
Equal Opportunity Employer/Protected Veterans/Individuals with Disabilities.
- Please view Equal Employment Opportunity Posters.
- The contractor will not discharge or in any other manner discriminate against employees or applicants because they have inquired about, discussed, or disclosed their own pay or the pay of another employee or applicant.
- However, employees who have access to the compensation information of other employees or applicants as a part of their essential job functions cannot disclose the pay of other employees or applicants to individuals who do not otherwise have access to compensation information, unless the disclosure is
- in response to a formal complaint or charge,
- in furtherance of an investigation, proceeding, hearing, or action, including an investigation conducted by the employer, or
- consistent with the contractor's legal duty to furnish information.