Packaging Section Leader

AVEVA DRUG DELIVERY SYSTEMS INC•Miramar, FL

1d•Onsite

About The Position

The Packaging Section Leader assists the Supervisor and provides daily leadership to employees in the Packaging department. The primary goal is to ensure safety and quality, maximize productivity and efficiency, and foster a positive work environment. This role involves planning and communicating daily production needs within the team, leading packaging employees on all assigned job duties, communicating overtime needs, and training new hires. The leader also performs the packaging of Aveva’s Transdermal and orally disintegrating film (ODF) products and clinical labeling of developmental products, while keeping the supervisor informed of all issues that occur on the shift. The position requires adherence to Current Good Manufacturing Practices and Standard Operating Procedures, continuous quality checks, and maintaining a safe working environment.

Requirements

High school diploma or general education degree (GED)
10+ years' experience in a fast-paced lean Manufacturing/Packaging (pharmaceutical manufacturing, food manufacturing) in a GMP environment required.
Demonstrate career progression within Aveva with a minimum of 3 years' experience as a Back-up Section Leader, or equivalent related experience.
Demonstrates thorough leadership, coaching skills, manufacturing expertise, safety measures knowledge, time management, organizational skills, and the ability to motivate workers.
Understands, adheres to, practices Current Good Manufacturing Practices (cGMPs) and to observe safety, environmental, and security policies and procedures during the performance of all assigned responsibilities.
Computer knowledge (e.g. JDE, Web Navigation, Email, MS Word and MS Excel).
Ability to read English and comprehend documents such as policies, Standard Operating Procedures, batch records and cleaning procedures.
Ability to write in English, and complete batch record documentation.
Ability to speak English effectively.
Must be able to use basic mathematical calculations in multi-level/complex formulas using whole numbers, common fractions, and decimals, following rounding and significant figure rules.
Ability to apply common sense understanding to carry out detailed written and oral instructions.
Ability to apply problem solving technics to address problems involving variables in standardized situations.
Ability to gather data/facts and assists with GMP investigations.

Nice To Haves

Transdermal Manufacturing/ Packaging experience preferred.

Responsibilities

Leads a team in the packaging and labeling of transdermal and ODF products.
Follows and enforce Current Good Manufacturing Practices and Standard Operating Procedures.
Creates monitor and maintain a safe working environment throughout the operation.
Performs continuous quality checks to assure product meets quality standards.
Utilizes packaging operators efficiently to meet daily requirements.
Assists in training operators in all phases of the packaging operation.
Maintains and cleans packaging areas and equipment.
Documents packaging steps performed in the batch record.
Weighs and documents weights of components, laminate, and finished product.
Sets-up and operates packaging machinery and equipment.
Documents operational parameter for packaging equipment.
Performs QC inspection of units and pouched units.
Performs accountability calculations.
Maintains cost consciousness throughout the operation.
Creates and revise Standard Operating Procedures.
Aids in the creation of batch records and any other document related to packaging process.
Writes discrepancy reports and investigations as needed.
Works as a member of a team to achieve all outcomes.
Operates in accordance with our Code of Conduct and Business Ethics, and all established regulatory, compliance and safety requirements.
Performs all work in support of our corporate values: Innovate, Evolve and Excel.
All other relevant duties as assigned.