POSITION SUMMARY
Provides clerical and general support to the Compliance / Quality Assurance department. Maintains system for record retention.
This position has no supervisory responsibilities.
DUTIES AND RESPONSIBILITIES
The essential duties and responsibilities include the following. Other duties may be assigned.
Demonstrates our core values: - Safety - Integrity - Service - Stewardship - Teamwork
Reads, understands and adheres to all appropriate Standard Operating Procedures and maintains understanding of Good Manufacturing Practices.
Responsible for database entry and management as directed.
Performs duties related to routine and special circumstance Document Control. Assists in oversight and performs duties related to SOP management including tracking, distributing, inactivating and archiving SOPs.
Maintains system and tracks current record retention documents for ease of retrieval and compliance with requirements.
Enters and scan new and current records into system and verifies accuracy of location and completeness of document
Maintains compliance with Code of Federal Regulations 21, Part 11 - Electronic Records.
Performs duties relating to SOP annual review and, as necessary for auditing SOPs, Handbooks, GIVERs.
Performs general clerical duties including photocopying and supply management.
Identifies and suggests opportunities for internal department process improvements.
Assists in internal and external communication of information by phone, email, calendar maintenance, meeting scheduling or in person as appropriate.
Coordinates surveys of internal and external customers as directed.
Performs duties related to ordering regulatory documents, forms, and supplies.
Education
Associates degree and/or equivalent experience.
Experience
One year or more of related experience required.
One to three years of related experience preferred.
Skills and Knowledge
Intermediate computer skills. Must possess or have capability to learn advanced computer applications.
Ability to read and interpret documents such as Standard Operating Procedures, safety rules, operating and maintenance instructions, and other department manuals.
Ability to read and understand simple instructions, short correspondence, and memos. Ability to write basic correspondence. Ability to effectively communicate with supervisor and other co-workers
Must have basic mathematical aptitude such as adding and subtracting two digit numbers and multiplication and divisions with 10's and 100's to be used for weight measurement, volume, distance, and money.
Ability to apply judgment to detail but very structured written or oral instructions and to deal with problems involving concrete variable in standardized work procedures.
Able to organize work to provide productive work flow.
Work independently and with minimal supervision.
Must be analytical with excellent problem solving skills.
Tools and Technology
Personal Computer (desk top, lap top, tablet)
General office equipment (computer, printer, fax, copy machine)
Microsoft Suite (Word, Excel, PowerPoint)
Working knowledge of regulatory (BBCS)
We embrace and encourage diversity in our workforce.
Equal Opportunity Employer of Minorities, Females, Protected Veterans, and Individuals with Disabilities.
We participate in eVerify.
We maintain a drug-free workplace and perform pre-employment substance abuse testing.
We are a tobacco/smoke-free workplace.