BackUp Section Leader Pkg

Date: Jan 23, 2023

Location: Miramar, FL, US, 33025

Company: Apotex

 

Aveva Drug Delivery Systems is a global leader offering a full range of research, development, and manufacturing capabilities to produce transdermal pharmaceutical products that can improve the quality of life, usage, and compliance rates for patients.

 

Job Summary

Assists Section Leader in providing daily leadership to employees in the packaging department to ensure safety and quality, maximizing productivity and efficiency while fostering a positive work environment, and performs duties of Section Leader in their absence. Plans and communicates daily production needs within the team. Leads packaging teams on all assigned job duties, communicating overtime needs, training of new hires, and helping R&D with new processes as Subject Matter Expert.

Job Responsibilities

  •  Assigns qualified personnel as required to meet weekly production schedule including overtime scheduling as needed.  Ensures personnel are properly trained and qualified before assigning tasks.
  • Performs daily review of batch documentation for accuracy and completeness.  At the end of the batch review all batch documentation for accuracy and completeness prior to submitting batch for review.
  • Ensures Operators monitor and document the critical process parameters during the packaging process. 
  • Investigates process problems, notifies supervisors, and takes appropriate corrective actions.
  • Performs batch processing steps in accordance with Batch Record packaging instructions and current labor standards in order to safely and efficiently package a quality product.
  • Verifies the correctness of all raw materials against the appropriate issuance documents to ensure that the correct materials are used during the packaging process.
  • Prints the required in-process labels for packaging processes in SAP.
  • Assembles, disassembles, and cleans equipment used for packaging in accordance with the applicable GMP procedure to ensure proper operation and cleanliness of the equipment.
  • Works with Quality Assurance and Engineering to ensure the packaging process meets quality specifications
  • Ensures that the packaging DLM boards are updated timely and reflect current information. 
  • Monitors production schedules, trouble shoots and solves problems.
  • Alerts Production Supervisor of all process-related problems so that appropriate action can be taken.
  • Complies with and enforces GMP dress code standards in order to minimize cross contamination, holding personnel directly accountable for compliance.
  • Follows all departmental and company safety policies in order to prevent injury to self and others.
  • Conducts training of new employees, new positions, new lines, and retrains when necessary. 
  • Backfills associates on the line when needed.
  • Trains and audits production employees to ensure current approved SOP’s are followed.  
  • Supports and promotes all Environmental, Health & Safety initiatives to ensure compliance with corporate and other regulations. 
  • Performs other duties in order to meet department's production schedule or to comply with cGMPs.

Job Requirements

Required Knowledge and Skills:

  • Demonstrates thorough leadership, coaching skills, packaging 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. SAP, Web Navigation, Email, MS Word and MS Excel).
  • Ability to read English and comprehend documents such as rules, 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 a few variables in standardized situations.

     

    Physical Requirements and Working Conditions:

  • Able to frequently lift and/or move up to 50 pounds.
  • Able to work wearing appropriate uniform, garments, and required safety equipment (safety shoes, eyewear, gloves and hearing protection following established cGMPs.
  • Use solvents for cleaning such as 70 % and 99 % IPA and any other cleaning solutions.
  • Able to stand, use hands and fingers, feel, handle, reach with hands and arms, talk or hear on a regular basis: walk and sit on a frequent bases and twist, stoop, kneel, balance and crouch on an occasional basis.
  • Must be available to work all shifts including daily and weekend overtime as needed.

     

    Environmental Conditions: Ability to concentrate and work in an environment where there is regular to moderate noise and, in some areas, frequent loud noise.  Work in an environment where there is occasional exposure to the following atmospheric conditions: Chemicals, dust, fumes, and smells.

    Minimum Qualifications:

    High school diploma or general education degree (GED) plus 7 + years’ experience in a fast paced lean Manufacturing/Packaging environment required, with Transdermal Manufacturing/ Packaging experience preferred; plus a minimum of 5+ years prior Manufacturing/Packaging experience in a GMP environment preferred (food manufacturing, pharmaceutical manufacturing,). Must be able to fluently read, write and speak in English

At Aveva Drug Delivery Systems, we are committed to fostering an inclusive, accessible work environment, where all employees feel valued, respected and supported. Aveva Drug Delivery Systems offers accommodation for applicants with disabilities as part of its recruitment process. If you are contacted to arrange for an interview or testing, please advise us if you require an accommodation.


Nearest Major Market: Fort Lauderdale
Nearest Secondary Market: Miami