Job Description
Assistant Manager - Dispensing
Detroit, MI
Duration: Full Time
Job Description
The Assistant Manager, Dispensing is responsible for managing all production-weighing operations and training personnel to meet all applicable CGMP, OSHA, DEA, FDA, and EPA regulations. Also organizes, coordinates, and monitors the activities of the production operations and interacts in the development and introduction of new products; oversees the achievement of capacity and production requirements based on the production schedule; and develops and leads initiatives to improve productivity of operations.
Essential Skills:
Essential Duties and Responsibilities:
The essential functions of the position include, but are not limited to:
• Oversees the activities of the dispensing area; accountable for achieving capacity and production requirements to achieve regular production schedules.
• Coordinates and implements production plans; establishes or adjusts work assignments to meet production schedule; establishes, reviews and improves procedures and systems for accomplishing production objectives.
• Oversees and approves ERP/ MRP transactions and is accountable for tracking consumption variance in raw material.
• Accountable for adhering to FDA, DEA, OSHA, and other governmental and company policies, objectives, and requirements.
• Performs investigations or production operational occurrences and determines corrective action.
• Interprets company policies to workers and enforces safety regulations and is accountable for enforcing and ensuring these requirements are followed throughout the department.
• Reviews critical production processes and equipment for adequate validation documentation; assists the validation activities by reviewing protocols, implementing qualifications and incorporating validated parameters into operational documents.
• Writes Standard Operating Procedures to cover critical production steps, equipment set up procedures, equipment and area cleaning procedures, and equipment operating procedures.
• Writes or assists in writing new or revised Manufacturing Batch Records to accurately reflect production operations, compendial requirements, product and process specifications assuring that each critical step is documented for operator performance and checked.
• Oversees the training or re-training of operators in the proper performance of assigned duties in accordance with SOP’s, cGMP’s, and all company regulations.
• Oversees the maintenance of adequate inventory of miscellaneous supplies to support the production schedule.
• Sets objectives, monitors progress and prepares annual performance appraisals for direct reports; reviews indirect staff’s appraisals.
• Addresses employee complaints and works with other department heads and/or Human Resources, as necessary, to resolve employee issues; compose performance improvements plans for employees with performance issues and reviews with Human Resources.
• Coordinates personnel activities along with Shift Supervisors – i.e., vacations, sick time, time cards, etc. to ensure there is appropriate coverage at all times.
• Conducts departmental and/or shift meetings with employees as necessary to communicate company information, audit updates, production schedule issues, etc.
• Accountable for assuring safety regulations and policies are adhered to and employees are properly trained on all safety procedures. Primary contact for safety audits and responsible for responding to and addressing any safety issues.
• Assures that all cGMP’s and housekeeping procedures and policies are followed. Responsible for proper cleanliness, organization, and orderly presentation of the facility to visitors, FDA, and to promote efficient operations.
• Responsible for tracking and improving material and labor variances to control costs and promote efficient operations.
SUPERVISORY RESPONSIBILITIES
Manages subordinate supervisors who supervise employees in the Dispensing Department. Is responsible for the overall direction, coordination, and evaluation of this unit. Also directly supervises one non-supervisory employee responsible for administrative duties,. Carries out supervisory responsibilities in accordance with the organization's policies and applicable laws. Responsibilities include interviewing, hiring, and training employees; planning, assigning, and directing work; appraising performance; rewarding and disciplining employees; addressing complaints and resolving problems.
Excellent working knowledge of associated industry and regulatory guidance documents and regulations e.g. FDA guidelines, OSHA guidelines, DEA requirements, state and government EPA laws.
Demonstrates technical expertise and knowledge of pharmaceutical solid dosage processes, and technical issues.
Required Skills
EDUCATION and/or EXPERIENCE
Bachelor's degree from four-year college or university; or a minimum of six years related experience and/or training; or equivalent combination of education and experience. Pharmaceutical manufacturing and a minimum of five years progressive management experience preferred. Business background and ERP/MRP II experience preferred.
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