Production Supervisor, 2nd/3rd shift (OSD Experience )

Job Description

Description:

Job Summary

The Supervisor, Production is responsible for daily coordination and execution of working schedules of people and equipment in Production line. Responsible for supervising operators that conduct Granulation, Drying, Blending, Compression, Pellet coating, Tablets coating and Encapsulation of drug products, including Granules branded, development & generic as well as contract customer products while meeting department quality, safety, delivery, and productivity objectives.

Supervisors are highly knowledgeable in cGMPs and good manufacturing practices; must be skillful at communicating, teaching, and inspiring colleagues to a high level of performance. Responsibility requires a high level of documentation, investigative writing, production planning and labor utilization skills. Reviews and releases batch record documentation; completes yield transactions or component returns. Ensures people and processes comply with Good Manufacturing Practices, company procedures. Initiates, and/or reviews department standard operating procedures to support business and quality objectives. Establishes and maintains cooperative cross-functional relationships with peers and leadership in Quality, Operations, Process Development, and Supply Chain to meet plant objectives. In partnership with the site leaders sponsors a quality and compliance focused site culture which embraces RFT (right first time) and CI (continuous improvement) expectations.

JOB DUTIES & RESPONSIBILITIES

Operations

Oversees hourly operators in execution of daily work; assures operators comply with validated parameters and standard operating procedures

Develops daily/weekly department work schedules, set priorities, and verifies availability of resources

Responsible for schedule adherence; participates in scheduling meetings with the objectives of increased resource utilization

Responsive to changes in daily workflow and schedule; determines needs and redeploys resources and/or overtime to achieve delivery and customer service commitments; adapts to ebb/flow of production process including changes due to unplanned maintenance or events requiring investigation

Ensure all equipment is working properly

Reviews batch records and supporting records prior to submission to Quality

Maintains a safe work environment

Completes in-process, set up checks and verification in alignment with Standard Operating Procedures

Compliance

Understands and adheres to good documentation practices (GDP)

Executes Quality Management System assignments (CAPA, Deviation, Change Control, Standard Operating Procedures etc.) to on-time closure

Obtains knowledge and executes assignments in QMS areas: deviation management and/or change control

Conducts investigations for cause, determines corrective action, and impact; writes reports and assures timely closure

Initiates and executes change control assignments in support of continuous improvement initiatives for equipment, documentation, or processes

Initiates work orders for equipment repairs or modifications

Creates, reviews, and conducts operator training programs and assures operator training is conducted on SOPs, cGMP, and safety

Assure and assist classroom and hands on training for batch records, SOP's, and cGMP's, and maintain proper documentation to ensure compliance

Follow and comply with company Safety policies and OSHA Regulations

Participates in development & maintenance of a safe manufacturing environment. Establishes methods in compliance with regulatory, plant, and corporate policies. Participates in safety meetings, investigates accidents, and takes appropriate corrective action to eliminate hazardous conditions

Supervisory

Reports production updates and schedule changes to team and/or at daily meetings

Assures hourly operators comply with all procedures, GMP regulations, safety, and contract obligations; provides constructive operator feedback

Assigns manpower; initiates documentation of violations and disciplinary action with operators as required

Requests equipment and facility repairs, or modifications

Understands and complies with Union Agreement

Keeps manager informed of operations; elevates as needed

Leadership

Reviews operational performance; drives improvement opportunities

Counsels, trains, and develops union colleagues for efficient performance; creates an atmosphere of team effort & open communication

Consistently communicate, follow, and enforce SOP’s and company policies and guidelines.

Troubleshoots or resolves issues impeding department daily/weekly objectives/deliverables; proactively demonstrates the ownership to achieve

Interfaces with suppliers of equipment or products and area consultants/experts

Conducts/supports CMO audits or regulatory agency inspections.

OTHER or ADDITIONAL RESPONSIBILITIES

Any other assignment allocated by Supervisor / Department Head.Requirements:

Minimum Education

Required- B.A. /B.S. Degree in Science, Business or related field or significant experience

Desired- B.A. /B.S. Degree in Pharmaceutical Sciences, Business management or related area

Minimum Experience

5+ years in a supervisory role within Pharmaceutical Manufacturing, Operations, or Quality Department with increasing levels of responsibility or equivalent

Must have expereince in OSD Manufacturing with increasing levels of responsibility

Knowledge

Knowledge of Quality MS (Management Systems), Document MS, and MS Office Suite

Solid understanding of all current state, federal and local standards, and regulations, e.g., cGMP, OSHA, FDA and DEA