QA Document Control Specialist Position Available In Palm Beach, Florida

QA Document Control Specialist Sofgen Pharmaceuticals, LLC 3874 Fiscal Court, West Palm Beach, FL 33404 PURPOSE The Document Control Specialist will be responsible for maintaining an organized and detailed library of documentation primarily using SharePoint. The Document Controls Specialist will be responsible for the administration and change control of documents that are received, created, or issued as part of the Quality System.

DUTIES AND RESPONSIBILITIES

Process documents for procedures, forms, etc. through change control system for revisions/changes. Store, manage and track company documents which includes scanning, uploading, archiving in accordance to company’s procedure. Provide additional support the Quality Unit as required including maintaining original Quality documents, loading PDFs into SharePoint, updating controlled lists. Coordinate with and assist company internal departments with hard copy and/or electronic documents in a timely manner. Communicates document requirements and client standards to Sofgen Departments Support Quality Team during audits with verification of document accuracy for requested documents. Verify completeness and accuracy of stored documentation, as well as appropriate file formatting. Performs periodic archiving and audits to maintain document repository standards. Compiles data for the preparation of metrics for the Quality Systems.

KNOWLEDGE, SKILLS, AND ABILITIES

High attention to detail Ability to work on multiple tasks and prioritize work Must be willing to work extended hours as necessary Ability to work independently Computer proficiency in Microsoft Office Applications Experience (i.e. Excel, Word, etc.) and data entry skills Actively participates as a member of the QA team to move forward with the completion of projects and goals. General understanding of basic quality assurance principles, FDA requirements Excellent interpersonal, verbal, and written communication skills

MINIMUM QUALIFICATIONS

High School Diploma or equivalent required. Associate degree or higher preferred . 2-5 years of previous document control experience in a quality assurance. environment, or alike environment. Basic Knowledge of FDA/manufacturing regulations. Proficiency in MS Word, Outlook, Excel, and PowerPoint. Proficiency in English usage, spelling, grammar, and punctuation. Effective planning and organizational skills. Strong communication and organization skills both verbal and written

SPECIAL FACTORS/WORKING ENVIRONMENT

Fast pace Pharmaceutical environment TRAVEL None

WORK ENVIRONMENT

This position works within a GMP Manufacturing Environment, office environment and inside the plant. The work environment, typical to an office environment, characteristics described here are representative of those encountered while performing the essential functions of this job. Pace may be fast and job completion demands may be high.

PHYSICAL DEMANDS

While performing the duties of this job, the employee is frequently required to talk, hear, use hands, handle or touch objects, and occasionally lift up to 25 lbs. Occasionally required to stoop, kneel, or crouch. Specific vision abilities required by this job include vision, depth perception and the ability to adjust focus.

Job Type:

Full-time Pay:

$20.00 – $22.00 per hour

Benefits:

401(k) 401(k) matching Dental insurance Employee assistance program Flexible spending account Health insurance Life insurance Paid time off Referral program Retirement plan Vision insurance

Schedule:

12 hour shift 8 hour shift Day shift Monday to Friday Night shift Weekends as needed

Experience:

Quality control audits: 3 years (Required)

CGMP:

1 year (Required)

Language:

Bilingual (Required) Shift availability: Day Shift (Preferred) Ability to

Commute:

West Palm Beach, FL 33404 (Required) Ability to

Relocate:

West Palm Beach, FL 33404: Relocate before starting work (Required)

Work Location:

In person