Backup Section Leader - PKG

Job Profile / Level Line of Business (LOB) or Business Process Stream (BPS) Department / Org Unit Production Operations Reports Directly To Supervisor / Sr. Operations, Production Operations Reports Indirectly To People Leader 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 a team of packaging employees on all assigned job duties, communicating overtime needs, training of new hires, and performs the packaging of Aveva’s Transdermal and orally disintegrating film (ODF) products and clinical labeling of developmental products. Keeps the section leader and supervisor informed of all issues that occur on the shift. Job Responsibilities Leads a team in the packaging and labeling of transdermal and ODF products 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. 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. Job Requirements Education – High school diploma or general education degree (GED) Experience – 7+ years experience in a fast‑paced lean Manufacturing/Packaging (pharmaceutical manufacturing, food manufacturing) in a GMP environment required. Transdermal Manufacturing/ Packaging experience preferred. Demonstrate career progression within Aveva with a minimum of 3 years experience as a Packaging Machine Operator, or equivalent related experience. Knowledge, Skills and Abilities – 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 methods to address problems involving variables in standardized situations. Ability to gather data/facts and assists with GMP investigations. #J-18808-Ljbffr Aveva Drug Delivery Systems