Aseptic Operations Manager-2nd Shift and 3rd Shift

Scope of Position

The Aseptic Manufacturing individual supervises the daily operations of a manufacturing area and ensures that all department operations are accomplished in compliance with cGMP/ISO regulations and meet production standards.

Responsibilities

Administrative Job Task- Time card management, personnel coaching, development, responsible for conducting 1:1 with employees, driving and sustaining an inclusive culture, supervising the daily activities of employees by providing training, direction, guidance, counseling, or disciplinary action when necessary, and, in conjunction with HR, make decisions regarding personnel actions (to include but not limited to hiring, terminations, promotions).

Responsible for adhering to manufacturing production schedule.

Expected to ensure all necessary components/resources are available and capable of meeting production schedule and established quality standards and goals.

Review of completed batch records.

Responsible for ensuring record corrections are completed in a timely manner not to impact the release of the product.

Quality System Management includes but is not limited to CAPA Investigations/LIRs and Internal Audit Observations.

Assist in achieving environmental, health, and safety goals by working safely and observing all general plant and department safety policies.

Perform all assigned duties according to departmental SOP's and cGMP's.

Remain current on proper procedures by reviewing current, revised, and new SOP's relating to the job and to the department.

Perform additional tasks as required to support product production, providing on-time delivery to customers.

Assist daily production in operating and monitoring technical, computerized, production machinery, ensuring quality standards are maintained.

Daily inspection of GMP logbooks

Perform other duties as assigned.

Qualifications

Bachelor's degree in business or the Sciences, or equivalent combination of education, training, and professional experience that provides the individual with the required knowledge, skills, and abilities.

A minimum of 3 years experience working in an Aseptic Production environment, Experience working in a GMP-regulated environment preferred.

Must have a minimum of two (2) years of experience in supervision.

Must have and maintain aseptic gowning certification and ensure all employees follow aseptic technique.

Knowledge and application of fundamental concepts of manufacturing, including CGMP/QSR.

Demonstrated supervisory ability.

Must have basic Math skills.

Demonstrate the ability to establish good working relationships with other departments, including vendors, colleagues, and subordinates.

Demonstrates the appropriate technical knowledge necessary to make sound decisions on development issues with minimal supervision.

Demonstrate the ability to analyze data and information and assess and resolve complex problems/issues as required.

Must be able to comprehend and follow all applicable SOPs.

Demonstrate knowledge and experience with electronic Quality Management Systems such as MasterControl and Trackwise.

Demonstrate a solid understanding of the appropriate knowledge of the current federal, local, and international regulations regarding the production, testing, and release of drug substances and products.

Good understanding of cGMPs, industry, and regulatory standards and guidelines.

Demonstrate familiarity with Microsoft programs like Word, Excel, PowerPoint, Project, Teams, Outlook, etc.

Demonstrate the ability to portray the appropriate level of integrity and professionalism.

Demonstrate the ability to communicate effectively with management, staff, regulators, and client representatives in written and verbal formats.

Demonstrate the ability to complete tasks accurately and according to established and shifting timelines.

Demonstrate the ability to make quality scheduling, resource allocation, and priorities decisions.

Energetic, execution-focused, self-motivated, and organized individual who is accustomed to working in a deadline-focused, high-pressure entrepreneurial environment.

Results-oriented and efficient.

Creative and open-minded who fosters an environment in which sharing of ideas is encouraged.

Demonstrate the ability to work closely with a diverse customer and employee base (internally and externally).

Demonstrate the ability to work well in a cross-functional team environment.

Must communicate fluently in English and have legible handwriting.