Job Summary:
Assists in the inspection and packaging of Avevas transdermal products and clinical labeling of developmental products, and occasionally leads a packaging team.
Job Responsibilities:
On a temporary or emergency basis fills in as packaging section leader.
Inspects commercial transdermal products during packaging.
Operates packaging equipment.
Cartons finished product.
Cleans packaging and production areas and equipment and documents it in appropriate logbooks.
Documents packaging steps performed in the batch record.
Weighs and documents the weights of components, laminate, and finished product.
Documents equipment critical operating parameters in the batch record.
Performs inspection of unit doses for all products.
Completes packaging batch record accountability.
Labels pouched units for clinical trials.
Assists the mechanics during the setup of the packaging lines.
Places units on moving web for developmental products.
Verifies current raw materials for batches and stages components and dedicated equipment parts for each batch.
Documents and dispose of all packaging waste on a per shift basis and at the end of each batch.
Closes, labels, palletizes and transports finished goods.
Performs standard testing procedures on daily basis.
Uses a pallet jack to transport finished goods and components.
Supports clinical labeling operations in any way possible.
Supports the manufacturing process in the finishing rooms.
Completes documents and perform all tasks necessary to swab equipment and/or areas.
Complies with Current Good Manufacturing Practices, Standard Operating Procedures, and safety polices while performing all job duties.
Performs other job tasks within production and in other departments 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 Values: Collaboration, Courage, Perseverance, and Passion.
All other relevant duties as assigned.
Education
High school diploma or general education degree (GED).
Experience
Minimum of six months experience and/or training; or equivalent combination of education and experience.
Knowledge, Skills and Abilities o An individual must be able to perform each essential duty satisfactorily.
o Ability to read English and interpret documents such as safety rules, Standard Operating Procedures, batch records and cleaning procedures. o Ability to write in English and complete batch record documentation.
o Ability to speak English effectively.
o Ability to add, subtract, multiply and divide in all units of measure, using whole numbers, common fractions and decimals.
o Ability to apply common sense understanding to carry out detailed but uninvolved written and oral instructions.
o Ability to deal with problems involving a few variables in standardized situations. o Knowledge of FDA, cGMPs, and SOPs related to job requirements. Physical Requirements and Working Conditions:
o While performing the duties of this job, the employee is regularly required to sit, stand and walk. The employee is frequently required to use hands to finger, handle or feel; reach with hands and arms; and talk and hear. The employee is occasionally required to stoop, kneel, crouch or crawl. The employee must frequently lift and/or move up to 50 pounds. While performing the duties of this job, the employee is regularly exposed to moving mechanical parts. The employee is frequently exposed to fumes or airborne particles and toxic or caustic chemicals. The noise level in the work area is usually loud. You may be required to work additional hours from time to time, including weekends. Shift hours are subject to change due to operational needs.
