Connexion Systems + Engineering
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Senior Scientific Associate, MTIA - Boston - 17709
Boston, MA 02210 US
Posted: 02/07/2023
2023-02-07
2023-04-27
Industry: Scientific and Life Sciences
Job Number: 15302
Job Description
Connexion’s mission is to provide "best in class" services to job seekers. We strive to achieve excellence in job placement, staffing, and recruiting services, while treating candidates with the professionalism and respect they deserve.
Title: Senior Scientific Associate, Manufacturing Technical Investigations and Analytics (MTIA)
Hiring Organization: Connexion Systems & Engineering
Compensation, Benefits, and Employment Type
position summary:
The Senior Scientific Associate, Manufacturing Technical Investigations and Analytics (MTIA) will have the primary responsibility is to support deviations, CAPAs, executed batch records and to provide continuous manufacturing PAT support at the Manufacturing Center. The Senior Scientific Associate, MTIA reports directly to the Sr. Manager, MTIA.
Key Responsibilities:
The responsibilities of this position may include, but are not limited to, the following:
Minimum qualifications:
Please use the apply button to submit your resume for consideration. A Connexion Representative will contact you immediately.
When responding to this job posting you MUST include the Job# and Job Title in your subject line.
If you are active in a job search but this job is not for you, please reach out to jobpostings@csetalent.com. We would be glad to help you find the perfect job!
Title: Senior Scientific Associate, Manufacturing Technical Investigations and Analytics (MTIA)
Hiring Organization: Connexion Systems & Engineering
Compensation, Benefits, and Employment Type
- Duration: Temp
- Job Location: Boston MA
- Pay Rate: $37-45/hr
- Job#: bh15302
position summary:
The Senior Scientific Associate, Manufacturing Technical Investigations and Analytics (MTIA) will have the primary responsibility is to support deviations, CAPAs, executed batch records and to provide continuous manufacturing PAT support at the Manufacturing Center. The Senior Scientific Associate, MTIA reports directly to the Sr. Manager, MTIA.
Key Responsibilities:
The responsibilities of this position may include, but are not limited to, the following:
- Performs Process Analytical Technology (PAT) Operator tasks during GMP manufacture.
- Lead, write and review deviations and investigations for the VMC, including the Drug Product Facility, Facilities, Materials Management and the Kilo Lab.
- Develop corrective/preventative action plans (CAPAs) through root cause analysis of deviations.
- Author and submit revisions to controlled documents in support of GMP Operations, including Standard Operating Procedures, Work Instructions and Master Batch Records.
- Review executed batch records to ensure compliance with GDP/GMP requirements.
- Apply GMP concepts and internally aligned interpretations of regulatory guidance to ensure consistent and compliant practices across GMP Operations.
- Assist team manager with project management tasks, including data analysis, preparation of team presentations, collection and summary of meeting notes
Minimum qualifications:
- BS/MS in chemical, mechanical, or material science engineering or comparable degree.
- Two or more years experience working in a GMP manufacturing environment in the pharmaceuticals, biotechnology or medical device industries.
- Understanding of cGMP concepts and general practices.
- Excellent planning and organizational skills, with the ability to balance production, development and continuous improvement needs.
- Experience working in Quality Management System for regulated documents (e.g., Veeva or Trackwise) is a plus.
- Formal training in root cause investigations and technical writing a plus.
Please use the apply button to submit your resume for consideration. A Connexion Representative will contact you immediately.
When responding to this job posting you MUST include the Job# and Job Title in your subject line.
If you are active in a job search but this job is not for you, please reach out to jobpostings@csetalent.com. We would be glad to help you find the perfect job!
