POSITION SUMMARY: Reporting directly to the Manager, Quality Assurance and under the general supervision of the QA Compliance & Administrative Specialist, the Document Control Admin & Trainer is responsible for maintaining organized and updated GMP-related documents. Their duties include using document management software to upload or scan paper documents, retrieving documents for authorized personnel and ensuring document storage to comply with in-house procedures and federal regulations.
- Scan and retention of all GMP-related activity documents.
- Quality review of Certificates of Conformity of sterile supplies to include Letco Lot and Item information, quality digital signature and upload to the Customer Relationship Management system.
- Fulfill all applicable document requests from Letco Account Managers and customers.
- Periodic review and documentation of all Document Control Room files for disposition (retention, off-site storage, destruction, etc.).
- Creation, issuance, and archiving of all site logbooks.
- Assist in developing and revising standard operating procedures (SOPs).
- Assists in investigations of internal quality issues.
- Performs/assists with customer/supplier complaint investigations and drafts customer response letters for
- Distributes associate training status reports to appropriate Department Manager.
- Performs new hire quality training and other quality training sessions, as
- Ensures all new hire and on-the-job training documentation forms are completed and submitted to Document Control in a timely manner.
- Maintaining organized and updated employee training files.
- Supports all regulatory and third-party audits of the facility.
- Other duties as required.
QUALIFICATIONS: To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
- EXPERIENCE AND EDUCATIONAL REQUIREMENTS: High School Diploma or GED equivalent required; associate or bachelor’s degree in a science related field or industry-equivalent experience preferred; minimum of two (2) years of progressive responsibilities in an administrative role or document control experience preferred; or an equivalent combination of education and experience. Experience in the pharmaceutical industry a plus.
- LANGUAGE ABILITY: Ability to read, analyze, and interpret general business periodicals, professional journals, technical procedures, or governmental regulations. Ability to write reports, business correspondence, and procedure manuals that are grammatically correct.
- MATH ABILITY: Ability to work with mathematical concepts such as probability and statistical inference and apply the concepts to practical situations.
- REASONING ABILITY: Ability to define problems, collect data, establish facts, and draw valid conclusions. Ability to interpret an extensive variety of technical instructions in mathematical or diagram form and deal with several abstract and concrete variables.
- COMPUTER SKILLS: To perform this job successfully, an individual should have advanced knowledge in the Microsoft Office suite of applications including Word, Excel, PowerPoint and Outlook and with Internet Explorer. Experience with electronic document control systems and electronic quality management systems preferred.
We believe in our people and foster a supportive environment that develops and rewards performance and incentivizes long-term career success. Our benefits include, but are not limited to:
- Competitive Salary
- Health, Vision, and Dental Insurance
- Company Paid Life Insurance
- Generous Paid Holidays
- Paid Volunteer Time
- Generous Paid Time Off and Rollover
- Company matching 401K and Retirement Savings Plans
- Employee Assistance Program
- Flexible working arrangements
Fagron North America is committed to creating a diverse environment and is proud to be an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race; creed; color; religion; national origin; sex; age; disability; sexual orientation; gender identity or expression; genetic predisposition or carrier status; veteran, marital, or citizenship status; or any other status protected by law. Fagron North America is proud to be an affirmative action and equal opportunity employer.