Document Control Specialist
About the job
This position completes all documentation services for manufacturing and Quality systems, including change control, technical writing, maintenance of records, and compliance with GMP documentation practices.
What you will be doing
- Communicate with foreign offices to receive and resolve customer complaints.
- Review all new complaints on a daily basis and enter into the database for trending.
- Trending of customer complaints and response letters for voice of customer.
- Submit retention samples for testing as needed.
- Create and review all master manufacturing records within the company.
- Create and review master manufacturing and packaging batch records.
- Create and review qualification batch records and track all necessary changes during the qualification process.
- Create and review rework batch records.
- Create and review replica batch records for use in the compounding and packaging areas.
- Maintains electronic and hard copies of all current and archived master batch records.
- Perform other duties and functions as assigned by management.
Skills and experience we would like to see
Posses a High School diploma or GED, plus four (4) years of specialized training provided through professional sponsored workshops, seminars, in-service or on-the-job training and three (3) to five (5) years experience or equivalent combination of education and experience.
- Experience in an office setting with controlled documents.
- Ability to write, review, understand and apply information set forth in Standard Operating Procedures (SOPs).
- Follow GMP standards and guidelines.
- Ability to handle confidential information.
- Ability to communicate effectively, verbally and in writing.
- Perform complex mathematical computations.
- Ability to understand and apply basic statistical principles.
- Ability to operate several computer applications such as Word, Excel, and Access.
- Ability to meet deadlines and manage work load with changing priorities.
- Strong interpersonal skills and great attention to detail.
After you have taken the time to review our open positions, you may be curious to discover how your talents align with shaping the future of Modere. You are more than just your resume. We understand. The resume is only the introduction to your story. A platform to begin a conversation.
So, are you ready to introduce yourself? Let's begin. Send us your resume and any additional links you would like for us to review. Feel free to begin with a brief intro. A standard cover letter just won’t do. We invite you to let us know what you are thinking at this very moment.
After you submit your information, time will elapse as we review responses. As we learn about you, we may discover that our paths intersect and we will want to meet you. It may be over the phone or in person. Be prepared. It is critical that you understand that we are selective. (We expect you are as well.)
This is an excellent time for you to reflect. Know who you are. Be comfortable being you. Know what drives you to be your best. Know what kind of people motivate you to be your best. Why are you considering a change of employment? What would a Modere employment opportunity mean for you?