REGINA F. WRIGHT

• 3-5+ years of experience in a cGMP warehouse environment and understanding of Supply Chain Management and APICS best practices for warehouse operations.
• Experience in the implementation and use of ERP/MRP software systems preferred.
• DOT/IATA/HazMat experience and certifications preferred.

Knowledge, Skills, and Abilities

• Knowledge of cGMP regulations and FDA guidance applicable to biologics and cell therapy manufacturing.
• Experience in:
• Distribution, receiving, temperature storage, issuance, and inventory control practices including cycle counting, and rejected/expired material disposition.
• Understanding controlled temperature, humidity, and pest control monitoring for cGMP environments.
• Transportation lanes and cold chain logistical movement of time critical and temperature sensitive biologics.
• Freight forwarder and courier direct shipments and associated documentation requirements.
• Use of material handling equipment – both gas powered, electric and manual.
• Operation of company owned vehicles for transport.
• Quality Systems for Deviation, SOP revisions/creation, CAPA Management
• Coordinates internal and external customer requests across multiple unit operations during their shift to include personnel, material, and logistical needs.
• Working with production planning, the Sr. Manufacturing Associate, and other shift leads to establish daily unit operations schedule that includes people, product, and material flow across multiple shifts.
• Completing and reviewing documentation required by process transfer protocols, validation protocols, standard operating procedures, and batch records.
• Assisting in the training of staff who are less experienced to ensure they have the necessary technical skills and knowledge.
• Initiation of company discrepancies/deviations for non-conforming materials and operational anomalies.
• Assisting in setting up warehouse operations equipment/fixtures. Perform facility and equipment commissioning activities, as needed.
• Reviewing and writing Warehouse Operations procedures that are technically sound, promote effective and efficient operations, and comply with cGMP requirements.
• Performing tasks in a manner that are consistent with departmental and corporate safety policies, quality systems and GMP requirements.
• Coordination and oversight of tasks performed by staff working within Warehouse Operations.
• Creating/writing Warehouse Operations procedures that are technically sound, promote effective and efficient operations, and comply with cGMP requirements.
• Additional duties, tasks and responsibilities as assigned by management.

Duties/Responsibilities

• Works on routine manufacturing assignments per written procedures, where ability to recognize deviation from accepted practice is required.
• Adheres to Good Manufacturing Practices and standard operating procedures.
• Measures and checks raw materials. Assembles, cleans and sanitizes process equipment and or assemblies.
• Completes work instructions and maintains clean room environment to comply with regulatory requirements.
• Trains for and ensures team members are proficient in the operation of primary production equipment within the assigned functional area.
• Is a subject matter in process systems (i.e. Syncade MES and Oracle interfaces) and some supporting business systems (i.e. Oracle, ETQ, BMRAM etc.).
• Own revisions and or creation of process documents, such as SOPs and electronic work instructions as well as workflow ownership in document management systems.
• Leads in maintaining material and components inventory level.
• Supports safe work environment and provides assistance for area specific initiatives associated with work safety.
• Work in teams and have continual interaction with members of his/her team as well as other manufacturing teams throughout the production process in order to exchange information regarding the batch(es) in process.
• Works on assignments that are routine in nature where judgment is required in resolving problems and making routine recommendations.
• Drives right first time (RFT) execution of manufacturing unit operations by providing direct training, guidance, and problem solving.
• Aids in daily work coordination and distribution as demanded through the production schedule.
• Is responsible for maintaining schedule adherence and cycle time. Reports variances and communicates impact to cross functional groups and supervisors.
• Provides shift handover and tier three communication working with other shift team members.
• Ensure shift notes communication is complete and accurate.
• Provide daily update summary for inbound and outbound shift members within responsible functional group for SQDCP.
• All other responsibilities delegated by leadership.

Knowledge, Skills, and Abilities

• Must be able to work in a cleanroom environment that requires gowning.
• Must be able to stand for extended periods of time.
• Required to carry and/or lift to 30 pounds several times a day while handling production equipment and/or materials.
• Required to push, and/or pull up to 50 pounds several times a day while handling production equipment and/or materials.
• Work in areas that may have strong magnets.
• Work in areas where handling human blood products (Biosafety Level 2) may be required.
• May work in areas with exposure to vapor phase liquid nitrogen.

• 0-3 years of experience in a cGMP warehouse environment and understanding of Supply Chain Management and APICS best practices for warehouse operations.
• Experience in the implementation and use of ERP/MRP software systems preferred.
• DOT/IATA/HazMat experience and certifications preferred.

Knowledge, Skills, and Abilities

• Knowledge of cGMP regulations and FDA guidance applicable to biologics and cell therapy manufacturing.
• Experience in:
• Distribution, receiving, temperature storage, issuance, and inventory control practices including cycle counting, and rejected/expired material disposition.
• Understanding controlled temperature, humidity, and pest control monitoring for cGMP environments.
• Transportation lanes and cold chain logistical movement of time critical and temperature sensitive biologics.
• Freight forwarder and courier direct shipments and associated documentation requirements.
• Use of material handling equipment – both gas powered, electric and manual.
• Operation of company owned vehicles for transport.
• Coordinates internal and external customer requests across multiple unit operations during their shift to include personnel, material, and logistical needs.
• Working with production planning, the Sr. Manufacturing Associate, and other shift leads to establish daily unit operations schedule that includes people, product, and material flow across multiple shifts.
• Completing and reviewing documentation required by process transfer protocols, validation protocols, standard operating procedures, and batch records.
• Assisting in the training of staff who are less experienced to ensure they have the necessary technical skills and knowledge.
• Initiation of company discrepancies/deviations for non-conforming materials and operational anomalies.
• Assisting in setting up warehouse operations equipment/fixtures. Perform facility and equipment commissioning activities.
• Reviewing Warehouse Operations procedures and providing input in ensuring documents are technically sound, promote effective and efficient operations, and comply with cGMP requirements.
• Performing tasks in a manner that are consistent with departmental and corporate safety policies, quality systems and GMP requirements.
• Coordination of tasks with staff working within Warehouse Operations.
• Additional duties, tasks and responsibilities as assigned by management.

• Greet and assist customers on sales floor and register
• Ensure accurate incoming/outgoing cash at register
• Built and maintained relationships with peers and upper management to drive team success.
• Stock and breakdown in inventory
• Arranged and stocked new merchandise following placement directions.
• Unloaded trucks, checked product and added warehouse tags.
• Followed cleaning and sanitation guidelines to meet health and OSHA requirements.
• Stocked sales floor and assisted in product movement and merchandising plans.

• 0-3 years of experience in a cGMP warehouse environment and understanding of Supply Chain Management and APICS best practices for warehouse operations.
• Experience in the implementation and use of ERP/MRP software systems preferred.
• DOT/IATA/HazMat experience and certifications preferred.

Knowledge, Skills, and Abilities

• Knowledge of cGMP regulations and FDA guidance applicable to biologics and cell therapy manufacturing.
• Experience in:
• Distribution, receiving, temperature storage, issuance, and inventory control practices including cycle counting, and rejected/expired material disposition.
• Understanding controlled temperature, humidity, and pest control monitoring for cGMP environments.
• Transportation lanes and cold chain logistical movement of time critical and temperature sensitive biologics.
• Freight forwarder and courier direct shipments and associated documentation requirements.
• Use of material handling equipment – both gas powered, electric and manual.
• Operation of company owned vehicles for transport.
• Coordinates internal and external customer requests across multiple unit operations during their shift to include personnel, material, and logistical needs.
• Working with production planning, the Sr. Manufacturing Associate, and other shift leads to establish daily unit operations schedule that includes people, product, and material flow across multiple shifts.
• Completing and reviewing documentation required by process transfer protocols, validation protocols, standard operating procedures, and batch records.
• Assisting in the training of staff who are less experienced to ensure they have the necessary technical skills and knowledge.
• Initiation of company discrepancies/deviations for non-conforming materials and operational anomalies.
• Assisting in setting up warehouse operations equipment/fixtures. Perform facility and equipment commissioning activities.
• Reviewing Warehouse Operations procedures and providing input in ensuring documents are technically sound, promote effective and efficient operations, and comply with cGMP requirements.
• Performing tasks in a manner that are consistent with departmental and corporate safety policies, quality systems and GMP requirements.
• Coordination of tasks with staff working within Warehouse Operations.
• Additional duties, tasks and responsibilities as assigned by management.

• Youth development and leadership workshops for various initiatives participation including: substance use prevention; effective community engagement;
• Census 2020; Voter engagement; COVID-19, etc
• Engage community through creative outreach strategies including PSA’s, social media, raffle giveaways and phone banking to share important information;encourage participation and direct community members to support
• Engagement includes the following initiatives: Census 2020; Voter
• Registration; Voting in the 2020 Presidential Election and COVID-19 Vaccination outreach efforts.