Technical Services Associate

KVK Tech is looking for a Technical Services Associate to join our team in Newtown PA.

This individual is responsible for providing technical and proposal writing support to the Technical Services division. Additionally, the position will also assist with development and delivery of process records for production. Additionally, writing investigations and Standard Operating Procedures, Technical Transfer Documents, and Validation reports. Execute all functions in accordance with current FDA regulations, ICH guidelines, USP methodologies, cGMPs and SOPs.

This position’s responsibilities will include, but not be limited to the following:

• Develop, write and review of technical documentation which includes manufacturing/packaging batch records.
• Ability to learn new techniques, perform multiple tasks simultaneously, keep accurate records, follow instructions, and comply with company policies.
• Manage the review, tracking, GMP compliance and approval of Change Controls for Production Processes, Facilities and Equipment.
• Develops, writes and reviews/updates SOPs.
• 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 ongoing basis.

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:

1. Preparation and approval of Standard Operating Procedures.
2. Preparation and review of Quality Risk Management for process, area and equipment.
3. Experience with quality improvement initiatives as needed.
4. Experience with development/writing of SOPs or other quality documents and/or reports as needed.
5. Complies with company policies and SOPs.
6. Good written and oral communication skills.
   

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.