Document Control Specialist
- Job Title
- Document Control Specialist
- Job ID
- CARROLLTON, TX 75006-6623
- Other Location
Swiss American CDMO LLC is a topical drug and medical device manufacturing company founded to provide cutting-edge topical skincare technologies to selected markets. Our business strategy consists of development, manufacturing and superior customer service to contract manufacturing customers worldwide. A strong team approach to serve our customers is the basis of our mantra – “Partnering to deliver service through quality, integrity, and commitment”. Are you passionate about Service Excellence, Results, Integrity and Leadership? These are the core attributes we are looking for at Swiss-American CDMO, LLC.
Document Control Specialist
The Document Control Specialist plans and conducts activities associated with the quality assurance and compliance of Cosmetic, Drug and Medical Device processes, materials, systems, and products by performing duties related to initiation, approval and closure of Change Management and Quality Records. This Document Control Specialist will ensure his/her activities maintain compliance with FDA, international/global regulations, and the ISO 13485:2016 standard as related to document control, change management, training, and batch record review/disposition activities.
Essential Duties and Responsibilities include the following.
- Ensure that QA functions are compliant with all required GMP regulations.
- Assist in the conduct of internal and external audits as necessary.
- Scan and file all training records, change management records and batch records as required.
- Assist the Document Control and Quality management with the biannual review of SOPs, uniPoint reconciliation/verification, vendor change control and customer changes as required.
- Assist the Document Control management with the monitoring and maintaining the site document control system including creation, revision, and approval SOPs as required as well as monitoring of metrics, performance indicators related to change management.
- Maintain and improve the level of GMP compliance and stay abreast of industry and regulatory compliance trends and requirements.
- Ensure that all operations are performed in accordance to SOP’s, FDA and GMP guidelines.
- Receive and analyze appropriate test results for the release of final product materials.
- Review and audit completed batch records, change controls, change requests, DCN records, SOP binders to verify compliance to governing procedures and regulations.
- Scan completed batch records into Laserfiche. Upload records into uniPoint. Complete tasks in uniPoint.
- Follow up with personnel on CAPA and NCR reports as well as any change related deliverable, training records, uniPoint or Laserfiche tasks.
- Four-year college or university program certificate; preferably in a Science or Engineering discipline or equivalent combination of education and experience.
- Minimum 3 years in a Manufacturing environment, in the Document Control, Batch Record review or relevant Quality/Compliance function.
- To perform this job successfully, an individual should have well to excellent knowledge of Microsoft Office Business Suite (word, excel, PowerPoint), Adobe Acrobat and Internet software; QMS software and efficiently generate certificates, Quality Records and electronic reports.
We value our employees’ time and efforts. Our commitment to your success is enhanced by our competitive annual salary, an extensive benefits package including paid time off, medical, dental and vision benefits, 401K plan with company match and future growth opportunities within the company. Plus, we work to maintain the best possible environment for our employees, where people can learn and grow with the company. We strive to provide a collaborative, creative environment where each person feels encouraged to contribute to our processes, decisions, planning, and culture.
We are an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability status, protected veteran status, or any other characteristic protected by law.