Operations Manager - Manufacturing and Packaging

Job Description

Job Description

Job Summary -

The purpose of this job is to oversee the production schedules in accordance with approved production instructions, standard operating procedures, while utilizing cGMP for the preparation of commercial product. Monitor and document in a periodic performance review the performance of the production staff. Identify opportunities for process and equipment improvements. Mentor staff and set goals and objectives for the production personnel.

Chestnut Ridge Operations 1st & 2nd shift

Key Accountabilities

Accountability & Responsibilities

Manufacturing Operations Management

• Assure the accurate execution of cGMP / DEA documentation relative to manufacturing and packaging activities.
• Assure the accurate manufacturing of bulk drug product for delivery to primary packaging without deviation.
• Assure the accurate packaging of drug product in approved primary packaging components without deviation.
• Assure the accurate sampling of raw material and the packaging of samples for shipment as appropriate to contract testing laboratories.
• Assure the accurate assessment of component inventory and reconciliation.
• Assure staff training requirements are established and complete prior to the performance of process or procedure.
• Assure the accurate performance of basic routine preventive maintenance of equipment and facility cleaning activities by operators.
• Establish performance Goals and Objectives based on facility needs and High Corporate Standards.
• Complete routine performance evaluations of staff and recommend growth opportunities.
• Assure adherence to established production schedules and monitor production performance as determined by the Plant Director.
• Monitor the general safety of staff and assure safe work practices are followed by all site personnel.

Education & Experience

Knowledge

Skills & Abilities

Physical Requirements