Job Summary:
Coordinate logistics to lead the fast-paced shipping department activity at a cGMP facility meeting daily customer demands by fulfilling orders on time and providing outstanding service on shipping options for the customer. Keep up to date on all small carrier changes, regulations, and customer needs. Pull, package, invoice daily orders within time constraints keeping up on lot traceable. Good organization, attention to detail will be required in this role.
Responsibilities:
Ensuring adherence to production schedules, regulatory requirements, and quality standards.Ensure efficient and accurate processing of orders.Coordinate and prioritize shipments based on production timelines, customer requirements, and regulatory guidelines.Ensure that all shipping activities comply with FDA regulations, cGMP (current Good Manufacturing Practices), and company SOPs (Standard Operating Procedures).Maintain accurate shipping records, including batch documentation, Certificates of Analysis (COAs), and shipping logs.Experience in customer service and computers or equivalent trainingAbility to work effectively with other teams.Ability to manage small projects personally and work independently.Ability to make decisions on box size and packaging with least cost to customer yet protects quality.Ability to work within a deadline under pressure and handle interruptions ensuring on time shipping for all customers.Ability to stand and walk for long periods, climb ladders, reach overhead, and lift up to 50 lbs. occasionally
Required Skills/Abilities:
Shipping experience UPS, USPS, FedEx.Excellent verbal and written communication skills. Excellent interpersonal and customer service skills.Excellent organizational skills and attention to detail.Excellent time management skills with a proven ability to meet deadlines.Strong analytical and problem-solving skills.Previous experience in a shipping environment.Ability to prioritize tasks and to delegate them when appropriate.Ability to function well in a high-paced and at times stressful environment.Proficient with Microsoft Office Suite or related software.Desire for continuous improvement and growthEducation and Experience:
High School Diploma or GED Required.Physical Requirements:
Prolonged periods of sitting at a desk and working on a computer.
Must be able to lift up to 50 pounds at times.
The application window for this position is anticipated to be open at least 25 days
Job Summary:
This position functions primarily in a classified ISO-7 environment and requires the individual to wear appropriate PPE. This position will support sterile filling operations and perform other duties, such as cleaning, restocking, visual inspection, and labeling, as required and/or assigned.
All assigned tasks must be conducted in adherence with all applicable procedures, cGMPs, company policies and any other quality or regulatory (Ex: OSHA, DEA, FDA, etc.) requirements. Facility is a multiple shift operation where variable shifts, including overtime and/or weekends, may be required.
Responsibilities:
Perform ISO-7 support functions for aseptic filling operations consistent with established protocols, procedures, and regulatory/cGMP requirements.Learn to utilize all relevant equipment/technology for filling operations.Responsible for acquiring and maintaining classified area gowning qualification.Complete and document required training to gain proficiency for all assigned job tasks.Accurately and contemporaneously document all actions performed per GDP standards.Assist with classified and non-classified area cleaning and maintenance as required.Perform visual inspection, labeling, and additional support tasks as required.Make recommendations for process improvements.Possess the ability to master multiple processes across different areas.Recognize and respond appropriately to equipment/documentation issues and deviations; obtain appropriate clarification and guidance from leadership before proceeding.Maintain a quality focused, “Right First Time”, attitude.Arrive for work on-time, prepared to work in the classified environment for the majority of each shift.Operate with Integrity by maintaining high ethical standards. Treat all employees with trust, respect, and professionalism. Speak up and hold others accountable for high integrity by providing constructive feedback. Take accountability for individual and team mistakes and participate in related corrective actions.Ensure patient safety by understanding you and your team’s impact on product quality.Excel within a diverse and high performing team. Remain open to new ideas and perspectives, communicate across shifts as required, and comply with site process to create a safe work environment. Demonstrate a passion to perform by meeting personal and departmental goals. Self-driven and self-accountable, performs required tasks, and progresses on qualifications within reasonable timelines.Demonstrate innovation abilities by identifying and speaking up about viable options for improvements and exploring and creating a path for implementation.Required Skills/Abilities: (examples)
Prior Sterile Compounding and Pharmaceutical Industry experience.Prior experience operating manufacturing equipment/machinery.Knowledge of FDA guidelines, cGMP, and GDP.Willingness to participate in training and gain other certifications as needed.Knowledge of basic arithmetic and chemistry calculations.Ability to work in a fast-paced environment with dynamic priorities and demands.Excellent written and verbal communication skills.Desire to expand knowledge and grow with the company.Leadership ability.Education and Experience:
High School Diploma or equivalent.Must pass a drug test.Must speak, write, and read English.Must be a team player.Must have excellent attention to detail.Physical Requirements:
Prolonged periods of sitting at a desk and working on a computer.
Must be able to lift up to 15 pounds at times.
The application window for this position is anticipated to be open at least 25 days
Job Summary:
This position functions primarily in a classified ISO-7 environment and requires the individual to wear appropriate PPE. This position will support sterile filling operations and perform other duties, such as cleaning, restocking, visual inspection, and labeling, as required and/or assigned.
All assigned tasks must be conducted in adherence with all applicable procedures, cGMPs, company policies and any other quality or regulatory (Ex: OSHA, DEA, FDA, etc.) requirements. Facility is a multiple shift operation where variable shifts, including overtime and/or weekends, may be required.
Responsibilities:
Perform ISO-7 support functions for aseptic filling operations consistent with established protocols, procedures, and regulatory/cGMP requirements.Learn to utilize all relevant equipment/technology for filling operations.Responsible for acquiring and maintaining classified area gowning qualification.Complete and document required training to gain proficiency for all assigned job tasks.Accurately and contemporaneously document all actions performed per GDP standards.Assist with classified and non-classified area cleaning and maintenance as required.Perform visual inspection, labeling, and additional support tasks as required.Make recommendations for process improvements.Possess the ability to master multiple processes across different areas.Recognize and respond appropriately to equipment/documentation issues and deviations; obtain appropriate clarification and guidance from leadership before proceeding.Maintain a quality focused, “Right First Time”, attitude.Arrive for work on-time, prepared to work in the classified environment for the majority of each shift.Operate with Integrity by maintaining high ethical standards. Treat all employees with trust, respect, and professionalism. Speak up and hold others accountable for high integrity by providing constructive feedback. Take accountability for individual and team mistakes and participate in related corrective actions.Ensure patient safety by understanding you and your team’s impact on product quality.Excel within a diverse and high performing team. Remain open to new ideas and perspectives, communicate across shifts as required, and comply with site process to create a safe work environment. Demonstrate a passion to perform by meeting personal and departmental goals. Self-driven and self-accountable, performs required tasks, and progresses on qualifications within reasonable timelines.Demonstrate innovation abilities by identifying and speaking up about viable options for improvements and exploring and creating a path for implementation.Required Skills/Abilities: (examples)
Prior Sterile Compounding and Pharmaceutical Industry experience.Prior experience operating manufacturing equipment/machinery.Knowledge of FDA guidelines, cGMP, and GDP.Willingness to participate in training and gain other certifications as needed.Knowledge of basic arithmetic and chemistry calculations.Ability to work in a fast-paced environment with dynamic priorities and demands.Excellent written and verbal communication skills.Desire to expand knowledge and grow with the company.Leadership ability.Education and Experience:
High School Diploma or equivalent.Must pass a drug test.Must speak, write, and read English.Must be a team player.Must have excellent attention to detail.Physical Requirements:
Prolonged periods of sitting at a desk and working on a computer.
Must be able to lift up to 15 pounds at times.
Job Summary:
This a light to medium experience required position that involves running and managing inventory that is necessary for production within a cGMP facility. The role extends to supporting the receipt, organization, picking, kitting, and shipping of both raw materials and finished goods. All inventory and supplies will run through this role as they are put into stock, picked for use, and also shipped out for selling. This is an entry level role with possibility for advancement.
Monday - Thursday from 5:00 AM to 3:30 PM
Duties/Responsibilities:
• Safely handles chemicals, corrosives, solvents, and other pharmaceutical compounds
• Ensures compliance with regulatory agencies such as OSHA, EPA, RCRA and company Guidelines
• Demonstrate physical ability to lift up to 50 pounds and push/pull pallets, product cans, etc. multiple times per shift.
• Demonstrates ability to stand and walk for extended periods of time.
• Manages inventory from receipt to shipment, ensuring materials are properly stored, picked up for production, and prepared for shipping.
• Supports the kitting of materials for production batches.
• Assists with the organization and layout of CNC/warehouse for efficient material flow.
• Maintains accurate documentation for all operations, including inventory levels and customer orders.
• Communicates with supply chain and production teams regarding inventory levels and production needs.
• Participates in monthly inventory counts and reconciliations.
• Strictly adheres to cGMP's, health and safety requirements, procedures and corporate policies.
• Adheres to all applicable procedures, cGMPs, D365 company policies and any other quality or regulatory requirements. (For example: DEA, FDA, etc.)
• Manages inventory from receipt to shipment, ensuring materials are properly stored, picked for production, and prepared for shipping.
• Supports the kitting of materials for production batches.
• Assists with the organization and layout of CNC/warehouse for efficient material flow.
• Maintains accurate documentation for all operations, including inventory levels and customer orders.
• Communicates with supply chain and production teams regarding inventory levels and production needs.
• Participates in monthly inventory counts and reconciliations.
• Strictly adheres to cGMP's, health and safety requirements, procedures and corporate policies.
• Adheres to all applicable procedures, cGMPs, company policies and any other quality or regulatory requirements. (For example: DEA, FDA, etc.)
Required Skills/Abilities:
Must be a team player and effectively collaborate with internal departments. Excellent attention to detail. Experience in a regulated manufacturing industry. Demonstrates ability to handle multiple responsibilities at any given time.
Education and Experience:
High School Diploma or GED Required
Minimum of 2 years of continuous work experience in warehouse, supply chain, and/or manufacturing role preferred.
5 years of general work experience preferred.
Physical Requirements:
Must be able to lift up to 50 pounds at times.
The application window for this position is anticipated to be open at least 25 days
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