Supervisor, Post Fill Manufacturing-Inspection & Packaging-3rd Shift

SUMMARY

The core function of the Supervisor, Post Fill Manufacturing, is the adherence to the Inspection and Packaging Schedule and managing the Inspection and Packaging resources to successfully complete the schedule. This includes the reviewing the schedule daily and preparing for work in the intervals of 24, 48 and 72 hours, delegating of tasks, managing personnel, certifications, training and development, holding teams and individuals accountable for performance and behaviors, addressing day-to-day operational obstacles, and executing batch record, logbook and other documentation reviews.

The Supervisor, Post Fill Manufacturing will supervise the day-to-day operations of their teams, ensure the required materials and tools are provided to their teams, distribute the workload, ensure the motivation is maintained, track performance through the metrics and tools provided and respond appropriately. A supervisor will interact with all teams and must maintain a level of professionalism to foster a team environment. This position will support our 3rd shift operations, 10pm-6:30am, Monday-Friday.

ESSENTIAL FUNCTIONS

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

• Ensure compliance with established cGMP regulations, Bora Pharmaceuticals policies, as well as Camden's SOP and Batch Record directions. Address and report any violations to the Manager.
• Directly monitor all inspection, labeling, and packaging procedures and ensure all finished product is properly identified and labeled.
• Ensure all documentation of client related operations are complete and verified in the batch records, protocols, room logbooks, and equipment logbook each day.
• Review completed batch records to ensure compliance with good documentation requirements and submit to QA in a timely manner.
• Participate in the scheduling of operations in the packaging area.
• Provide personal leadership for the continuous improvement of quality and effectiveness
• with Production.
• Supervises Group Leaders/Technicians within the Packaging Department to inspect, label, and package parenteral products at the Camden Facility and conduct performance appraisals for all direct reports.
• Responsible for the timeliness of the submission of timesheets for direct reports and self.
• Observe and adhere to all company policies and procedures, and ensure that department members also abide by those policies. Report to Supervisor/Manager any violations of those polies and procedures.
• Ensure that direct reports are provided with adequate training to execute their respective tasks in a safe and effective manner.
• Ensure that direct reports understand the expectations of their respective jobs per the job description that defines their area of responsibilities and provide direct reports with counseling and guidance as needed for career or professional growth and development.
• Ensure that direct reports are provided with opportunities (example: classes) to supplement their existing knowledge base.
• Assist quality assurance personnel in obtaining documentation when required.
• Review all logbooks in the inspection, labeling, and packaging areas.
• Coordinate equipment needs with equipment technicians to ensure availability for operational activities.
• Delegate personnel to keep up-to-date inventory of all product storage areas.
• Monitor the inventory and order components as required for the routine operation of the inspection, labeling and packaging areas.
• Provide assistance with deviation investigations and provide input to root cause analysis and resolution.
• Gain knowledge and be able to provide training on batch record documentation, inspection technique, defect segregation, defect detection, and any aspect of Inspection and Packaging job requirements deemed necessary by Management.

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

• High School Diploma or equivalent with Minimum of 2-3 years of experience or
• Educational experience beyond a High School Diploma preferred.
• Working knowledge of computers and electronic data processing.
• Working knowledge of modern office practices and procedures.
• Skill in operation of listed tools and equipment.
• Ability to effectively meet and communicate with co-workers and clients.
• Ability to make independent judgments which have minor impacts on the organization.

Compensation Range:
$75,789.00 - $113,684.00
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