Analyst III, QA Document Control

SUMMARY

The role of the Analyst III, QA Document Control requires advanced knowledge and understanding of electronic document management systems (EDMS). This individual must be knowledgeable with GDocP and cGMPs regulations. This position serves as a subject matter expert (SME) for the site in regards to EDMS.

ESSENTIAL FUNCTIONS

Reasonable accommodations will be made to enable individuals with disabilities to perform the essential functions.

Key responsibilities associated with this role include but are not limited to the following:

• Excellent working knowledge of the electronic document management systems (EDMS) program (Veeva).
• Act as a trainer on EDMS and other GDocP functions (i.e., serialization, DCC workflows, etc.).
• Issue documents (batch records, logbooks, lab notebooks, etc.) in a timely manner to support site operations.
• Provide support during regulatory and internal inspections.
• Respond to internal and external audit findings.
• Prepare and present reports and metrics to leadership around documents (DCCs, periodic reviews, document reconciliation, etc.)
• Revise Quality Assurance SOPs and Work Instructions as required to ensure procedures are compliant with cGMP.
• Maintain records archives both on-site and at off-site archive facility.
• Support cross functional teams/departments in troubleshooting technical issues related to Document Control.
• Additional Quality Assurance activities / support activities as required (Training of peers for document control, QA Release, etc.).

The above statements are intended to describe the nature of work performed by those in this job and are not an exhaustive list of all duties. Nothing in this job description restricts managements right to assign or reassign duties and responsibilities to this job at any time which reflects management's assignment of essential functions.

MINIMUM EDUCATION, EXPERIENCE, SKILLS

• Degree in a scientific discipline or equivalent level of skill and experience.

• 3-5 years' experience with cGMP, FDA regulated industry, and/or electronic document management systems.
• Demonstrated success in independent judgment, technical proficiency, collaboration with others in a cGMP environment.
• Strong skills with Microsoft Office suite
• Excellent attention to detail
• Ability to effectively communicate (oral and written) with internal customers at all levels of the organization.
• Ability to work individually and as part of a team with minimal supervision.
• Ability to work on multiple assignments simultaneously and prioritize tasks to meet deadlines.

Compensation Range:

Bora PharmaceuticalsInjectables, Inc.is committed to providing equal employment opportunity to all applicants and employees according to all applicable equal opportunity and affirmative action laws, directives and regulations of federal, state and local governing bodies and agencies. In keeping with this commitment,Bora PharmaceuticalsInjectables, Inc.will recruit, hire, train and promote persons in all job titles, without regard to race, color, creed, religion, sex (including factors related to pregnancy or child birth), national origin, age, marital status, familial status, disability, sexual orientation, gender identity status with regard to public assistance, employment status, local human rights commission activity, status as a protectedveteran,genetic information, atypical hereditary cellular or blood trait, or any other protected category