What are the responsibilities and job description for the Specialist L, QA Data Integrity position at Upsher-Smith Laboratories, Inc.?
JOB SUMMARY
The Data Integrity Specialist will be responsible for assisting the Baltimore 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. A good understanding of the computer system validation to the software development life cycle is necessary.
ESSENTIAL FUNCTIONS
Reasonable accommodations will be made to enable individuals with disabilities to perform the essential functions.
- 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
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
- Bachelor’s degree in science or engineering from an accredited university or college
- A minimum of seven (7) or more years of relevant cGxP experience in a biopharmaceutical or life sciences development or manufacturing environment in calibration, validation, operations, engineering, or any combination thereof
- Experience with investigations into deviations and determination of impact, root cause, and corrective actions
- Knowledge of pharmaceutical equipment, such as bioreactors, centrifuges, CIP skids, autoclaves, parts washers, HVAC systems, building chillers, clean steam generators, WFI generation, storage and distribution, RODI water system, and Temperature Controlled Units (e.g., refrigerators, freezers, and incubators) is an advantage.
- Demonstrated success in independent judgment, technical proficiency, and collaboration with others in a cGMP environment.
- Must be a team player and able to work cross-functionally in a matrixed environment.
- Must have excellent written and verbal communications skills.
- Excellent organizational and interpersonal skills.
- Ability to work as part of a high performing team and collaborate effectively with staff at all levels, and across all functions
- Demonstrated ability to manage multiple activities while maintaining a high level of organization
- Demonstrates initiative; ability to undertake additional responsibilities and respond to situation as they arise with little or no supervision
- Ability to make independent sound decisions and independently manage priorities in alignment with department and company goals
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
About Us
Bora Pharmaceuticals is focused on developing and manufacturing branded, generic and over the counter (OTC) healthcare and pharmaceutical products for patients around the globe. At Bora Pharmaceuticals, we see it as our mission and our duty to make our mutual success more certain. As an ambitious, future-focused company, we know better than most that our own success is shaped by our partners victories.
Salary : $91,719 - $137,579
