Bora Pharmaceuticals
I. JOB SUMMARY
The Operations Specialist is responsible for direct support of process improvement and compliance directives associated with the manufacturing activities at the Bora Pharmaceuticals Camden facility. Direct performance of process deviation investigations, supporting corrective/preventive action (CAPA) creation and ownership, and change control generation, ownership, and execution in support of all Camden manufacturing processes.
II. ESSENTIAL FUNCTIONS
Reasonable accommodations will be made to enable individuals with disabilities to perform the essential functions.
- Individual will be liaison between Quality Assurance and other departments to ensure Manufacturing commitments are completed in a compliant manner. They will operate in a cohesive fashion.
- Required to work with some supervision by senior staff and with other departmental or non-departmental personnel.
- Investigation and writing of non-conformances such as deviations, complaints, OOS, OOT, deviations, etc.
- Reviewing process, product and equipment related validation and stability protocols and reports
- Technical review of SOPs and processes
- Developing and implementing process improvements
- Participates in Manufacturing Process Improvement Teams.
- Other assigned responsibilities as established by Manager.
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.
III. MINIMUM EDUCATION, EXPERIENCE, SKILLS
- BS degree in Engineering, Business/Operations, or related discipline with 4-6 years GMP experience required, 2-3 years production supervision experience desired.
- MS or MBA degree in Engineering, Business/Operations, or related discipline with at least 2 years Manufacturing experience may be substituted.
- Ability to make sound decisions regarding compliance-related issues with moderate supervision.
- Must have strong attention to detail.
- Ability to manage multiple priorities and tasks in a dynamic environment.
- Strong communication skills (written and verbal) and strong organizational skills.
- High level of personal/departmental accountability and responsibility.
- Ability to exercise judgment to determine appropriate corrective actions.
- Ability to use computer programs such as Access, Excel, SAP and an electronic document management system.
- Ability to work in a team environment and to work within that team to maximize efficiency and throughput.
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.
Compensation Range:
$68,891.00 – $103,337.00
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
