MGS Mfg. Group has an exciting opportunity for a Document Control Specialist at our Richfield, WI molding facility. The Document Control Specialist is responsible for managing company documents, while also ensuring their accuracy, quality, and integrity. The Document Control Specialist ensures adherence to record retention policies, batch record review, and more effectively data retrieval. This position also ensures that Certificates of Analysis (CoA) are prepared correctly and submitted to customers in a timely manner.
Below are the essential duties and responsibilities:
- Know and follow all of the Company’s safety rules, such as safe work practices and standard operating procedures.
- Serve as a good role model to employees for safe work practices and behavior by conducting yourself professionally, keeping in mind your own safety and the safety of others.
- Learn and master all necessary areas of the quality system.
- Follow Good Manufacturing Practices (GMP) and Good Documentation Practices (GDP).
- Review production batch records in accordance with Good Manufacturing Practices (GMP) and uphold the standards of the Quality Management System (QMS).
- Monitor processes for adherence to established procedures/regulatory compliance.
- Compiles, reviews, and completes production batch records, including raw and test data results, in an efficient and timely manner. Assure that any observations/deviations are properly investigated and explained.
- File and maintain batch records in accordance with GMP and internal procedures.
- Creates, adjusts and maintains filing systems for current and archived product master records (PMR), product history records (PHR), and batch records.
- Maintain process window and control plan log. Ensure updates are made per the review frequency.
- Organize completed inspection records with the production records.
- Manages and organizes inbound and outbound product documentation.
- Processes document change requests.
- Prepare Certificates of Analysis (CoA) in an efficient and timely manner. Assure that all customer specific requirements are satisfied.
- Generate C of A upon receipt of product release authorization.
- Retain all results from outside laboratory testing.
- Assist in the documentation and resolution of non-conformances and escalate quality concerns as needed.
- Write/revise documents, as necessary, and in accordance to good documentation practices.
- Assist in the generation and resolution of corrective and preventive action plans (CAPAs) as needed.
- Assist in 2ndand 3rd party audits.
- Act as a backup to the Document & Data Control Coordinator.
- Any other duties as assigned.
Keyword: data control, quality, ISO
Required Experience:
A qualified candidate would fulfill these requirements:
- High school diploma or equivalent is required.
- 2 to 4 years of experience and/or training, or equivalent combination of education and experience.
- Experience in working with team.
- Good working understanding of Microsoft Word, Excel, PowerPoint, and Outlook.
- Ability to prioritize, multitask, and manage time well.
- Excellent listening, oral, and written communication skills.
- Extremely detail oriented.
- Self-directed, ability to work independently, and highly-motivated.
- Quality Control/Assurance knowledge is preferred, but not required.
As a global provider of healthcare manufacturing solutions, MGS provides the right balance to drive vital innovations: robust end-to-end solutions combined with the strong customer focus and seamless collaboration of an agile partner. That’s why we’re the engineering and manufacturing partner of choice for today’s leading Pharma, Diagnostic and MedTech innovators. Serving customers from 12 strategically located facilities around the world, we transform our customers’ most pressing challenges into innovations that improve lives. To learn more about MGS, please visit www.mgsmfg.com.
Benefits:
We offer an excellent benefits package including medical, dental, vision, 401K, disability, life, vacation, and holidays.
From: MGS Mfg. Group, Inc