Careers

We currently have an opening for a Quality Specialist at our New Jersey facility. This role will lead the Quality function and will have one direct report. If you are a personable and proactive Quality professional with experience in clinical trial packaging and labelling, pharma manufacturing or pharma distribution, we would like to hear from you.

What you will do:

·       Lead the QA function at the New Jersey facility

·       Manage all controlled GMP documents

·       Initiate and handle EQMS reports (i.e. Deviation, CAPA, Change Control, etc.) reports as required

·       Qualify GMP Equipment/Systems/Facilities

·       Ensure all regulatory and quality-related documentation is maintained in accordance with relevant SOPs and regulatory requirements

·       Plan and conduct required Quality training for all employees (i.e. GMP, SOPs, etc.)

·       Provide support for customer and regulatory inspections

·       Conduct supplier and customer verification/qualification and approval

Your qualifications, skills and experience include:

·       5 or more years in a QA role in CTS or pharma manufacturing/distribution

·       A degree or diploma from a recognized college or university

·       Experience leading and coaching a QA/QC team preferred

·       In depth knowledge of FDA and New Jersey Dept. of Health regulations and guidelines

·       Knowledge of Health Canada regulations preferred

·       Strong written and verbal communication skills

·       Ability to prioritize

·       Team player who works well with others

·       A commitment to providing excellent internal and external customer service

We are seeking a Warehouse Associate for performing the daily warehouse activities at our New Jersey facility. The role requires a strong focus on warehouse safety, following policies and procedures, quality, client satisfaction and product logistics. The ideal candidate will have the ability to learn procedures and processes in a GMP warehouse environment, can prioritize a high volume of tasks and is able to perform accurate data entry in CRM systems. The Warehouse Associate will be responsible for daily operations to ensure timelines are met, and all products are received, inventoried, and stored in accordance with warehouse schedule and company policies and procedures.

This is a contract position for 6 months with a potential to move to permanent

What you will do:

- Responsible for all inbound and outbound shipments including client specific request.

- Receive inbound products as per procedure and store products in appropriate temperature storage conditions.

- Update the inventory logs and update the ERP system for inbound and outbound products.

- Inspect clients incoming shippers, conditioning and storing.

- Preparation, Handling, labeling & packaging of shipments.

- Perform conditioning of the temp-controlled shippers and gel packs.

- Complete Destruction list of expired products monthly.

- Responsible for daily updates of the temperature monitor log sheet.

- Ensure appropriate SOP forms are completed when required for audit documentation purposes.

- Responsible for notifying QA of any issues that may impact the quality and integrity of the products.

- Responsible for dispatching and prioritizing shipping schedules as instructed.

- Assist in mitigating risk and in resolving any issues with shipments (e.g., delayed shipments).

- Assist with auditing to ensure accuracy of product and logs.

Your Skills, Qualifications and Experience:

- GMP warehouse environment experience preferred.

- Knowledge of warehousing, shipping, inventory management, SOPs for Pharmaceutical supply chain management.

- Familiarity with the use of hand trucks, pallet jacks, forklift and other relevant warehouse equipment.

- Physical stamina and dexterity with the ability to lift and move at least 50 lbs.

- Computer literacy, proficient in MS Office suites and CRM systems preferred.

- Ability to prioritize and meet deadlines in a fast-paced environment

We are currently looking for a Quality Manager - EU to join our growing team. If you are a seasoned Quality professional with leadership experience in the CTS, secondary packaging and labelling or pharmaceutical industry, this might be the role for you.

The Quality Manager - EU will be appointed by the RxSource Executive Team as the Management Representative to oversee all activities in the Quality department within Europe and will ensure the implementation and continued development of the Quality Management Systems of all RxSource Limited divisions (Sourcing, Clinical Trial Services, Distribution, Medical Devices, and Regulatory Affairs). The person in this role will work closely with the global QA team to ensure processes are harmonised across the three RxSource sites.

This is a pivotal leadership role that requires the candidate to have proven Quality experience, strategy, strong communication and analytical skills to fulfill RxSource’s vision, mission and values.

What you will do:

• Maintain compliance to all relevant standards and legislative requirements pertinent to EU regulations
• Foster, lead and embed a strong culture of quality in RxSource Limited
• Lead and develop the quality team at the Ireland location
• Work with the global QA team to implement an Electronic Quality Management System and continued development of Integrated Management Systems
• Manage regulatory, customer and vendor inspections
• Ensure that initial and continuous training programs are implemented and maintained within all divisions of the organisation
• Manage the Change Control process, ensuring controlled implementation of all GxP related changes in accordance with relevant SOP’s
• Review and approve Corrective and Preventive action (CAPA), including tracking, follow-up, and evaluating CAPA effectiveness.
• Lead and manage the QA responsibilities under the Manufacture and Importation Authorization (MIA) including Qualified Person (QP), ensuring implementation and continued development of the quality system and good manufactures practices (GMP)
• Lead and manage the QA responsibilities for the Packaging and Labelling activities, ensuring implementation
• Conducts validation/qualification of GMP Equipment/Systems/Facilities
• Communicate frequently with all the departments to ensure information flows seamlessly (QA, Logistics, Project Management, Sourcing, Purchasing, Operations, HR and Regional Teams etc.)

Your experience, skills and qualifications:

• 3+ years of QA experience in clinical trials, pharmaceutical or medical devices
• Solid knowledge of European regulations and guidelines
• A Diploma or Degree from a recognized College or University or equivalent working experience
• Proficient in MS Office - including Outlook, Word, Excel, PowerPoint, OneNote, Teams
• Supervisory experience preferred
• Experience working with Electronic Quality Management Systems (e.g. TrackWise, etc.)
• Professional level grammar and excellent proof-reading skills
• Excellent communications skills (verbal, written, listening, conveying messages)
• Detail-oriented
• Solid decision-making skills
• Highly adaptable, flexible professional who embraces teamwork, but also enjoys working independently
• Experience working with colleagues across different Global time zones
• Willingness and flexibility to travel as required