Production Assistant Manager - Pharmaceuticals

Ingenus Pharmaceuticals

Fairfield, NJ

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JOB DETAILS

SALARY

$129,189–$132,000 Per Year

JOB TYPE

Full-time, Employee

SKILLS

Biotech and Pharmaceutical, Calendar Management, Capsules, Corrective Action, Corrective and Preventative Action (CAPA) Systems, Cross-Functional, Documentation, Documentation Review, Documentation Standards, Dosage Forms, Drug Manufacturing, ERP (Enterprise Resource Planning), FDA Requirements, Forecasting, GMP (Good Manufacturing Practices), Industry Standards, Inventory Management, Lean Manufacturing, Lean Six Sigma, Maintain Compliance, Manufacturing, Manufacturing Operations, Manufacturing Process Planning, Manufacturing/Industrial Processes, OSHA, Operations Processes, Performance Tuning/Optimization, Pharmacy, Process Improvement, Product Documentation, Production Planning, Production Schedule, Quality Assurance, Quality Control, Quality Engineering, Regulations, Reporting Skills, Research & Development (R&D), Resource Management, Risk Analysis, Root Cause Analysis, Safety Process, Safety/Work Safety, Sales, Standard Operating Procedures (SOP), Supply Chain, Team Lead/Manager, United States Drug Enforcement Agency (DEA), Validation Plan

LOCATION

Fairfield, NJ

POSTED

2 days ago

Production Assistant Manager - Pharmaceuticals: Fairfield, NJ: Enforce compliance of current Good Manufacturing Procedures standards including in reviewing documentation related to product processes including batch records, validation protocols, and Standard Operating Procedures. Ensure and enforce compliance with GMPs, DEA, OSHA regulations, SOPs, Master plans, Batch records, Ingenus Policies and industry standards. Responsible for scheduling production activities with management according to the Sales Order and Order Forecast. Handling day-to-day activities on the shop floor and ensuring that good manufacturing practices are being followed by working subordinates. Provide support to the operator, group leader and supervisor in the daily management of the department activities. Responsible for ensuring documentation timelines and perform risk assessments and root cause analyses to address deviations and non-conformances. Collaborating with cross-functional teams, including research and development to resolve. Ensure accurate system inventory is maintained through the performance inventory reconciliations, facilitation of material delivery review, and other related activities. Conduct internal investigation related to product failure deviations. Lead safety related programs. Write safety incident reports, near misses and take corrective actions. Plan and lead manufacturing process improvements and other LEAN initiatives to optimize performance and drive short and long-term business improvement. Conduct internal investigations relating to quality, safety, and personnel. Establish and maintain document numbering, version control, and revision history for all production documents. Coordinating document movement across all functional groups Imparting training to new employees and other subordinates. Ensure that all documentation related to each task above is performed as per the operating procedure. Ensuring the availability of Materials for manufacturing process and co-ordination with Quality control, Quality assurance and Engineering departments for smooth flow of manufacturing and packaging operations. Maintain accurate and up-to-date manufacturing documentation. Review history documentation for accuracy and product release. This position supervises others.

Requirements: Applicants must have a Master’s degree (or US Equivalent) in Pharmaceutical Science, Pharmacy or related field. Must have two (2) years’ experience in pharmaceutical production. Experience in Good Manufacturing Practices (GMP), and regulatory standards including FDA, MHRA, and WHO guidelines is required. Must have a detailed understanding of effective scheduling, estimating, and workflow processes in a generic pharmaceutical environment. Hands-on experience in pharmaceutical manufacturing processes, specializing in solid dosage forms such as tablets and capsules, as well as liquid formulations. Experience with ERP systems, Pragma platforms, Standard Operating Procedures (SOPs) and batch manufacturing records documentation. Demonstrated experience in initiating and reviewing written procedures such as standard operating procedures (SOPs), operating instructions, cleaning procedures, safety procedures, and other work procedures is required. Experience in Production Planning & Scheduling, Supply Chain Coordination, Lean Manufacturing / Six Sigma, CAPA Management (Corrective and Preventive Actions) and Resource Allocation (Man, Machine, Material) are required. 40 hours per week M-F: 9:00 a.m. to 5:00 p.m. Must have proof of legal authority to work in the United States. Salary: $129,189 - $132,000 per year. To be considered, please visit Ingenus Pharmaceuticals’ career website at https://www.ingenus.com/careers/ and apply by emailing your resume to hr@ingenus.com Job Number:52026

About the Company

Ingenus Pharmaceuticals

INDUSTRY

Biotechnology/Pharmaceuticals