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Available Positions

Available Positions

 

PRODUCTION SUPERVISOR NIGHT SHIFT(Corporate Office)

 

RESPONSIBILITIES:

  • Work with compounders verifying completion of crucial manufacturing steps.

  • Record and check data onto charts, batch records and logbooks.

  • Evaluate process and equipment requirements and prepare recommendations accordingly.

  • Review equipment availability and preparedness in conjunction with the schedule.

  • Schedule daily and weekly workload, anticipating and pro-actively addressing any potential problems or delays.

  • Evaluate existing formulas and SOP’s for accuracy. Revise and/or write originals as required.

  • Provide guidance, direction, and training for compounders, autoclave operators and equipment prep. personnel.

  • Monitor safety and take positive steps to eliminate hazardous situations, alerting other departments and personnel as necessary.

QUALIFICATIONS:

  • Minimum of a BA or BS in chemistry or related field.

  • 5 years experience in a pharmaceutical or manufacturing environment.

  • Strong written and verbal communication skills

  • Proficiency in MS Word and Outlook.

  • Strong project management skills.

  • Ability to lift 50 pounds routinely.

 

 

PROJECT MANAGER (Corporate Office)

RESPONSIBILITIES:

  • Responsible for all aspects of project management for Quality Assurance, Quality Control and Manufacturing.
  • Possess a clear understanding of the QA, QC and manufacturing process in the pharmaceutical industry.
  • Facilitate problem-solving and decision making with respect to project deliverables and meeting timelines.
  • Monitor project budgets to provide updates to the Executive Management Team with needed.
  • Provide input on project team member performance to aid the functional heads in employee performance evaluations.
  • Fully understand business cases including all internal and external factors which may derail the project and alert senior management of any potential pitfalls.
  • Communicate all pre-defined events to team members and other stakeholders according to communication plan. Monitor and communicate any changes in project scope, timeline and cost to all appropriate individuals.

QUALIFICATIONS:

  • Bachelors Degree in Business or Science, MS or MBA preferred.
  • 3 years project management experience in pharmaceutical environment.
  • Exceptional influencing and team development skills.
  • Superior organizational skills, must be able to manage multiple projects with high priority.
  • Effective communication skills, both verbal and written.
  • Solid presentation skills.
  • Proficient in Project Management Software.

 

SUPERVISOR, STERILITY ASSURANCE(Corporate Office)

RESPONSIBILITIES:

  • Provide oversight for assurance of sterility at Luitpold including facility renovations, use of disinfectants and any other critical procedures.

  • Revise current SOPs and write new SOPs as needed.

  • Initiate Change Controls, as needed

  • Review and sign all monographs.

  • Write investigations into out of specification or limits occurrences.

  • Write validation protocols and final reports.

  • Coordinate with Research and Development Department to carry out special projects, as needed.

  • Maintain all necessary documentation for all activities.

  • Offer input/ suggestions for improvement in laboratory operations and procedures.

  • Participate in customer or FDA audits

  • Plan work schedule for Microbiologists

  • Train and provide technical assistance and guidance to microbiologists

  • Perform or assist in performing annual performance reviews for staff.

  • Mentor and supervise Sterility Assurance staff.

  • Assume managerial role in Associate Director’s absence.

QUALIFICATIONS:

  • Minimum of a Bachelor’s degree in Microbiology, Biology, or a related field.

  • Minimum of 4 years experience in a pharmaceutical microbiology laboratory.

  • Must have at least 1 year supervisory or leadership experience, preferably in a scientific environment.

  • Proficient in MS Word, Excel and Outlook.

 

TRACKWISE ADMINISTRATOR (Corporate Office)

RESPONSIBILITIES:

  • Manages the project plan, including tracking against all major milestones and deliverables.
  • Communicates with project stakeholders throughout the project life cycle.
  • Coordinates meetings and schedules necessary resources throughout the project life cycle.
  • Escalates issues through Sparta or the Company, as appropriate.
  • Evaluates risks and defines risk mitigation plan.
  • Reviews validation documentation, as needed by the CSV team.
  • Reviews documents written by Sparta, as applicable.
  • Participates in all aspects of the project, from requirements gathering to Go-Live and Support.
  • Assists in business process definition and TrackWise requirements gathering.
  • Maintains regular contact with Sparta and participates hands-on in configuration activities.
  • Manages the User Acceptance Testing of Workflow Activities for the End User Team.
  • Learns the system in order to conduct Go-Live support and assists in end-user training.
  • Assists in the functional testing of the system.
  • Primary TrackWise system contact with Sparta Support Services.
  • Training of end users for their specific workflow processes.
  • Drive requested form/workflow/report modifications using a risk based approach to determine validation/regression testing requirements.
  • Day to day troubleshooting and end user assistance requests.

QUALIFICATIONS:

  • Bachelor’s Degree in Computer Science or equivalent.
  • 3 years Trackwise Systems Administration experience in pharmaceutical environment.
  • Exceptional influencing and team development skills.
  • Superior organizational skills, must be able to multi task system related items with high priority.
  • Effective communication skills, both verbal and written.
  • Solid presentation skills.
  • The TrackWise Administrator must have experience with the Microsoft office suite: Word, Access, Excel, Visio, PowerPoint and Project.
  • Crystal Reports development experience.

 

AMERICAN REGENT MULTISOURCE SALES REPRESENTATIVE (Field Based)

RESPONSIBILITIES:

  • This position calls on health care professionals in assigned sales territory and communicates product advantages, features and benefits, plays a vital role in fostering the Company's reputation and image.

  • Achieves or exceeds sales objectives through promotion of contracted and non-contracted Generic products to our key accounts: Hospitals, Infusion Centers, Surgery Centers, Home-Infusion companies, Pharmacy Compounding Centers, Distributors and Wholesalers in the assigned territory.

  • Builds relationships with pharmacy directors and their staff and other key customers by personally visiting them, and educating and influencing them to purchase or choose American Regent Generic products.

  • Ensures that wholesalers in assigned territory maintain adequate levels of American Regent Generic products to meet needs of customers serviced by these particular distribution centers.

  • Serves as a pharmacy products expert and provides a high level of expertise and customer service for all accounts.

  • This position will be based in either Philadelphia or Washington DC and cover from Southern New Jersey through North Carolina.

QUALIFICATIONS:

  • Bachelor's Degree. Some pharmaceutical product knowledge a plus.

  • Two years plus sales experience, business to business or pharmaceutical sales strongly preferred.

  • Self motivated, organized and disciplined.

  • Strong verbal and written communications skills

  • Proficient in MS Word, Excel, PowerPoint and Outlook

  • Willing to travel extensively

 

TRADE SHOW COORDINATOR(Corporate Office)

RESPONSIBILITIES:

  • Trade Show Coordinator to handle all administrative tasks in the coordination and attendance of trade shows including processing of all paperwork required for participation in trade shows, all travel arrangements, and maintaining accurate records and files for all trade shows attended.

  • Will be working with Marketing Department to review and provide all necessary materials for trade shows, help develop advertising materials.

 

QUALIFICATIONS:

  • Bachelor’s degree required with either trade show experience or experience coordinating large complex projects.

  • Must be proficient in MS Word, Excel, Illustrator and Photoshop.

  • Must be highly organized and thrive in a fast paced environment.

 

 

CLINICAL QUALITY AUDITOR (Norristown, PA)

 

RESPONSIBILITIES:

  • Responsible for maintaining quality and ensuring that studies, documents, and submissions to federal agencies meet required industry and federally specified standards (Good Clinical Practices)

  • Plan, schedule, and conduct internal and external quality audits including audits of clinical sites, vendors, partners, and collaborators to ensure compliance with regulations, agreements, and SOP’s.

  • Evaluates the potential risk of compliance deficiencies identified in quality reviews or audits. Reviews corrective and preventative action plans and audit responses.

  • Perform QA/QC activities associated with Pharmacovigilance systems.

  • Perform QA/QC activities associated with Device Quality systems.

  • Development and maintenance of Clinical Quality Assurance SOP’s and audit schedules.

  • Perform quality reviews of documents and regulatory submissions.

  • Ensure independent reporting of quality deficiencies to CQA Management and Executive Management.

 

QUALIFICATIONS:

  • Bachelors’ Degree in Life Sciences or equivalent qualification and relevant experience.

  • Ability to perform a range of project based internal/external GCP audits, clinical site audits, TMF Audits, and vendor audits.

  • Three years of monitoring/auditing experience (preferably in GCP)

  • Thorough knowledge of ICH, GCP, FDA and appropriate regional clinical research regulations and guidelines.

  • Strong problem solving, risk assessment and impact analysis, and root cause analysis abilities.

  • Excellent oral and written communication skills.

  • Overnight travel required

 

 

CLINICAL RESEARCH ASSOCIATE (Norristown, PA)

 

RESPONSIBILITIES:

  • Assist with Administration of clinical research projects: recruiting, investigators, collecting investigator documentation, site management, site monitoring, preparing status reports and completing other technical tasks to completion.

  • Initiate, monitor and close-out clinical investigative sites under supervision from Project Managers, Clinical Regulatory Managers, and Medical Directors.

  • Provide ongoing assistance and education of investigational sites in principles of Good Clinical Practice (GCP) as it relates to Research involving human subjects.

  • Ensure subject safety through diligent monitoring of the site’s compliance with study protocols and the collection of adverse event information

  • Update, track and maintain study specific trial management tools/system.

  • Monitor Case Report Forms (CRF) for missing implausible data. Assess compliance with study drug handling procedures. Ensure that all adverse events are collected pursuant to GCP.

  • Report, write narratives and follow-up on reported serious adverse experiences.

  • Assist with generation and reconciliation of queries to investigation sites to resolve problem data.

  • Assist and manage project budget and investigator site budget, attend project team meetings, plan and attend investigator meetings, and communicate with clients.

  • Generate and track drug shipments and storage.

  • Provide coverage to clinical contact telephone lines. Provide answers to common protocol related questions under the supervision of the Project Manager and Medical Director.

 

QUALIFICATIONS:

  • Bachelor’s degree required. Preferred degree in the Biological / Health Sciences.

  • Pharmaceutical industry experience a plus.

  • Minimum 3 years experience in Drug Development, Regulatory Affairs, CRA experience. Dialysis, Rheumatology, Oncology, Cardiology, Pediatrics or GI experience preferred.

  • Ability to travel up to 80%, including overnight

  • Strong multi-tasking abilities and able successfully handle multiple priorities simultaneously. Detail oriented, self-motivated

  • Proficiency in MS Word, Excel and Outlook. Knowledge of Medical/Regulatory Terminology

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