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

Granules•Chantilly, VA

45d

About The Position

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.

Requirements

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

Nice To Haves

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

Responsibilities

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
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
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
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
Any other assignment allocated by Supervisor / Department Head.