What are the responsibilities and job description for the Technical Services Supervisor position at KVK Tech?
KVK Tech is looking for a Technical Services Supervisor to join our team in Newtown, PA.
The Supervisor of Technical Services is responsible for department activities in providing technical and proposal writing for the organization. This includes writing Standard Operating Procedures, Technical Transfer Documents, Validation Reports, Manufacturing Batch Records, Protocols, Pre-Development and Pharmaceutical Development Reports, investigations and other various documents. Additionally, the position will assist with the development and delivery of process records for production.
This position’s responsibilities will include, but not be limited to the following:
- Develop, write and review/update R&D SOPs, and technical documentation which includes Manufacturing/Packaging batch records.
- Writes Development protocols and reports for R&D.
- Prepares documentation for submission of new ANDA filings.
- Assists in the response to FDA deficiency letters for ANDA filings for answering Pharmaceutics related findings.
- Prepares various summary forms for Pharmaceutics related projects as well as graphs, charts and statistical analysis for establishing product specifications.
- Designs, develops and implements databases to track key project deliverables and resource allocation within Pharmaceutics and updates on an on-going basis.
- Prepares presentations to share project status updates.
- Implements Document Management.
Benefits Include:
401(k) with matching
Health, Vision, Dental Insurance
Childcare Scholarship
Tuition Reimbursement
Bonus Pay Merit Increases
Paid Time Off
Flexible Holidays
We are looking for applicants with:
- Minimum 3 years experience working in a pharmaceutical company preparing technical documents preferred
- Strong organization skills, attention to detail, and the ability to work in a team and fast paced environment.
- Experience in statistical analysis, process capability reviews with software.
KVK Tech is an affirmative action/equal opportunity employer and does not discriminate in hiring or employment on the basis of age, sex, race, color, religion, national origin, gender identity, veteran status, sexual orientation or any other protected status.
We encourage you to apply if you feel that you are a match! We look forward to hearing from you.
