What are the responsibilities and job description for the Specialist I, QA Data Integrity position at Bora Pharmaceuticals?
JOB SUMMARY
The Data Integrity Specialist will be responsible for assisting the Camden facility in determining systems that are impacted by data integrity requirements. The position requires thorough understanding of data integrity and 21 CFR Part 11 requirements. Role requires working with cross functional teams to identify computerized needs for new systems, upgrading systems and decommissioning to ensure proper equipment is used and compliant. The position requires strong technical knowledge of computerized laboratory and enterprise systems, GAMP processes, and risk management. Strong mechanical aptitude with manufacturing equipment in aseptic GMP facility.
ESSENTIAL FUNCTIONS
Reasonable accommodations will be made to enable individuals with disabilities to perform the essential functions.
- Provides technical expertise on GMP equipment that supports the Data Integrity Program.
- Provides technical quality review and approval of validation, technical documents, facilities, and maintenance documents to support Quality Systems, i.e., work orders, calibrations, preventive maintenance.
- Represents Quality in key decision-making regarding requirements for CAPEX and validation projects.
- Has a broad expertise or unique knowledge, uses skills to contribute to development of company objectives. Achieves goals in creative and effective ways.
- Serves as change agent for continuous improvement within the scope of work.
- Frequently interacts with direct manager and other cross functional peers to gain alignment on sound quality decisions.
- Provide support during regulatory and internal inspection activities as needed.
- Coordinate / lead cross-functional teams in process mapping and other exercises designed to facilitate process and system understanding.
- Must work independently and manage time.
- Must be detail oriented and conduct thorough reviews and approve documents on behalf of Quality Systems.
- Review and approve other documents as needed.
- Support and partner GMP departments across the site
- Onsite support for manufacturing team
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.
IMINIMUM EDUCATION, EXPERIENCE, SKILLS
IV. PHYSICAL / MENTAL DEMANDS AND WORK ENVIRONMENT CHARACTERISTICS
The physical / mental demands are representative of those that must be met by an individual to successfully perform the essential functions of the job.
The work environment characteristics described here are representative of those an individual would encounter while performing the essential functions of the job.
Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
Compensation Range :
91,719.00 - $137,579.00
Bora Pharmaceuticals Injectables, 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 Pharmaceuticals Injectables, 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 protected veteran, genetic information, atypical hereditary cellular or blood trait, or any other protected category
Salary : $91,719 - $137,579
