Document Control Specialist I

SUMMARY

The Document Control Specialist I is responsible for assisting in maintaining Standard Operating Procedures (SOPs) and change management activities for pharmacy operations and manufacturing under direct supervision of the Supervisor of Document Control. The job includes tasks such as processing SOPs for creation, revision, collaboration, approval, distribution, obsolescence and communicating information that can be used to train staff on new and updated processes. This position works closely with operations, distribution, lab services, QA, QC, management, and other cross-functional groups. Applicants for this role should be computer proficient, be able to manage their time, prioritize tasks effectively, and be able to demonstrate high-level accuracy and attention to detail.

ESSENTIAL DUTIES AND RESPONSIBILITIES include the following. Other duties may be assigned.

* Utilizes current SOPs to process documents and resolve basic documentation issues in accordance with the document lifecycle process, from creation through obsolescence.

* Learns and utilizes Quality Management System (QMS) document and change control modules for day-to-day activities.

* Routes SOPs for review when needed to maintain adherence to review schedules.

* Begins to learn processes in pharmacy operations, distribution, and laboratory services to accurately document and update SOPs.

* Interviews, listens, and observes colleagues/departments while they perform business functions to gather necessary information to create drafts of these processes.

* Prepares and presents draft documents in approved formats to subject matter experts (SMEs), management, and other cross functional teams.

* Updates existing SOPs to align with changes in new processes and system functionality after collaboration with SMEs.

* Collects and consolidates input from SMEs, management, and other team members; communicates with appropriate personnel to facilitate resolution of discrepancies and ensure consistency of documentation.

* Presents draft documents in approved formats to Documentation Manager.

* Routes and tracks completed SOPs for approval according to established timelines.

* Develops a working knowledge of applicable laws, regulations, and accreditation standards to ensure SOPs are compliant.

QUALIFICATIONS:

EDUCATION AND/OR EXPERIENCE

* Bachelor's degree in business management or scientific/technical field.

* Zero to one year experience writing SOPs and/or equivalent work processes within a regulated industry.

* 1 to 2 years of experience working in a regulated industry preferred.

* Must have demonstrated competence in use of computing equipment with strong working knowledge of Microsoft Word and Excel.

* Ability to learn new software applications as needed.

COMPETENCIES (SKILLS AND ABILITIES)

* Basic communication skills both verbal and written.

* Ability to build stable and productive working relationships with internal personnel and functions as part of a team.

* Ability to troubleshoot and resolve simple conflicts through collaboration with geographically dispersed teams.

* Initiative, possession of organizational skills, and attention to detail.

* Prepares clear, concise documents for general and technical needs.

* Completes work while maintaining confidential information.

* Detail oriented; routinely assess the accuracy of documents and spot formatting problems and errors.

* Able to identify when issues require input from SMEs to resolve efficiently and effectively.

* Computer skills: MS Office Suite.

Salary may vary depending on factors such as confirmed job-related skills, experience, and location.

However, the pay range for this position is as follows. Sales Positions are eligible for a Variable Incentive

We offer the following benefits for you to take advantage of while you are here provided you meet the eligibility requirements under each governing program:

* 401k savings & company match

* Paid time off

* Paid holidays

* Maternity leave

* Parental leave

* Military leave

* Other leaves of absence

* Health, dental, and vision benefits

* Health savings accounts

* Flexible spending accounts

* Life & disability benefits

* Identity theft protection

* Pet insurance

* Certain positions may include eligibility for a short term incentive plan

Covetrus is an equal opportunity/affirmative action employer. All qualified applicants will receive consideration for employment without regard to sex, gender identity, sexual orientation, race, color, religion, national origin, disability, protected Veteran status, age, or any other characteristic protected by law.