Career Opportunities

Analytical Quality Control Chemist II

Summary

The Chemist II of Analytical Quality Control has responsibility of performing complex testing of raw materials and finished products, maintenance and calibration of analytical instruments in compliance with cGMP. The position will provide assistance to analytical quality control manager to meet projects timelines and improve laboratory compliance.

Primary Responsibilities

  • Perform routine/non-routine testing, both wet chemistry and instrumental analysis, according to SOPs, testing methods, protocols, compendia (USP EP/JP) etc with minimum supervision.
  • Participate in analytical method validation for intermediate precision study.
  • Involve testing of raw materials, APIs, finished products, stability samples, and cleaning verification samples, etc.
  • Proficient at HPLC/GC analysis
  • Document laboratory work according to cGMPs and SOPs 
  • Troubleshoot, calibrate and maintain instruments as required.
  • Prepare and label laboratory reagents, reference standards, or solutions according to SOPs.
  • Write SOP's, laboratory protocols and reports, memos and/or other interdepartmental correspondence
  • Initiate and resolve laboratory investigations.
  • Train and provide guidance to entry level QC personnel and be a subject matter expert in laboratory practices.
  • Perform peer review of analytical documentation.
  • Follow safety procedures when working in laboratory.
  • Understand and comply with cGMPs and other regulations. 
  • Maintain the laboratory in an organized and neat manner.

 

Qualifications

  • BS degree required, preferred in science degree. Require minimum of 3 years quality control working experience.
  • Familiar with fast paced contract manufacturing environment and be able to work under pressure while maintain high quality.
  • Experience working with potent, or cytotoxic materials preferred. 
  • Working experience with parenteral drug products preferred.
       Back to Top

 

Jr. Systems Administrator

The Jr. Systems Administrator assists in the installation, maintenance, and general support of systems.  Provides occasional technical support to users via e-mail, phone, the support ticketing system, or via other methods.  Must possess an advanced level of understanding of technology used within the organization; will be expected to elevate complex inquiries to the appropriate parties.  Will work under general supervision of the Systems Administration Manager.  Will have the opportunity to assist with an upcoming systems merger, including active directory domain merge, e-mail system transfer, and SAP deployment.

Primary Responsibilities

  • The Jr. Systems Administrator will be expected to accept trouble reports and resolve or dispatch them to the appropriate team member.  Will be required to work directly with users to resolve reported issues.
  • Perform advanced troubleshooting on support requests to determine the appropriate course of action.
  • Performs routine tasks using experience and judgment, occasionally under the supervision of a more experienced team member.
  • Performs documentation creation and updates.
  • Perform and maintain procedures for preparation and deployment of user equipment as well as decommissioning of equipment.
  • Perform research related to systems and services to develop/discover processes for implementation.
  • Maintain accurate inventory of supplies and equipment such as laptops, desktops, monitors, printer consumables, etc.
  • Assist with installation and maintenance of the company’s systems under supervision of a more experienced team member.
  • Assist with monitoring system backups and performing data recovery under direct supervision of a more experienced team member.
  • Assist with tasks and projects as requested by department management.

Qualifications

  • Minimum Associate’s degree required, Bachelor’s degree preferred, in computer science or a related field.
  • One to three years of experience in computer system administration.
  • A certificate in computer science or a related field.
  • Strong interpersonal and communication skills, including the ability to explain advanced procedures in writing or verbally.  Must possess the ability to train users in applications and operating system fundamentals.  Must have the ability to research and assist with composition of purchase justifications, and make presentations to an internal audience.
  • Possess the ability to independently solve problems; should have a strong sense of self-direction.
  • Strong skills with Windows operating system commands and utilities.
  • Strong understanding of server hardware and software.
  • Basic understanding of networking concepts.
  • Must be familiar with most basic system administration tools and processes.  For example:  ability to boot/shut down a machine, add and remove user accounts, use backup programs and command line utilities, manage shared resources (e.g. file systems, printers), add a workstation to a network, mount remote file systems, etc.
  • Understanding of distinctions between system processes/services and user processes, local and network resources and resource sharing, as well as basic networking concepts and practices.
  • Familiarity with networked/distributed computing environment concepts.
  • Ability to write scripts in some administrative language (such as Perl, Python, VBScript, Windows PowerShell).
  • Strong understanding of cGMP documentation requirements and FDA regulations related to computer systems.   
       Back to Top

 

Manufacturing Inspector & Labeler

The Inspector and Labeler position performs production activities including equipment and room preparations, inspection, labeling and packaging, collaborates effectively with other functional groups to ensure production goals are achieved and investigations are completed in a timely manner.

Primary Responsibilities

  • Line clearances, cleaning, preparing of rooms and equipment.
  • Operate and maintain inspection, labeling, and packaging areas and equipment.
  • Maintain records and a clean environment to comply with regulatory requirements.
  • Read, understand, and comply with Good Manufacturing Practices and Standard Operating Procedures.
  • Review/update current SOPs as well as write new SOPs if required.
  • Lead troubleshooting and process improvement activities including corresponding documentation activities.
  • Review completed production documentation for quality and compliance.

Qualifications

  • High school education or equivalent.
  • Minimum of 3 years of experience in an aseptic manufacturing environment.
  • Must be familiar with a variety of production equipment.
  • Team player committed to quality and working effectively with others.
       Back to Top

 

Manufacturing Operator

Summary

The role of the manufacturing operator is to perform production activities including Equipment preparation, Formulation, Filling, Inspection, and Packaging. Collaborates effectively with other functional groups to ensure production goals are achieved and investigations are completed in a timely manner.

Qualifications

  • High school education or equivalent.
  • BS in Biology, Microbiology, Chemistry, Bio-Tech or Engineering preferred (current students may apply).
  • Experience in an aseptic manufacturing environment preferred.
  • Must be familiar with a variety of production equipment.

Primary Responsibilities

Line clearances, cleaning/sanitization, cleaning, preparing and sterilization of fill equipment, sterilization of components, operation of aseptic filling equipment, filter testing, operation vial washing equipment
  • Operate and maintain production equipment.
  • Weigh, measure and check raw materials to assure batches manufactured contain proper ingredients and quantities.
  • Execute validation protocols for processes and equipment.
  • Maintain records and a clean environment to comply with regulatory requirements.
  • Read, understand, and comply with Good Manufacturing Practices and Standard Operating Procedures.
  • Review/update current SOPs as well as write new SOPs.
  • Lead troubleshooting and process improvement activities including corresponding documentation activities.
  • Review completed production documentation (batch records, log books, etc.) for quality and cGMP compliance.
  • Initiate appropriate action when process deviations occur.
  • Perform on job training for new and developing operators.

Other duties as assigned by leadership team.

       Back to Top

 

Microbiology Technician

Summary

The Microbiology Technician is responsible for performing and maintaining the environmental monitoring programs for the facilities and water systems used at CLI. The Microbiology Technician will aide Microbiology Staff in sample collection, operation of test equipment, and trend data entry to facilitate the compliance aspect of the microbiology laboratory.

Primary Responsibilities

  • Perform environmental monitoring throughout batch production.
  • Assist in the performance and documentation for environmental monitoring of the facilities and water systems in compliance with Standard Operating Procedures.
  • Adhere to all applicable regulations, policies, and procedures for health, safety and environmental compliance. 
  • Aide in completion of environmental monitoring related investigations through coordination and communications with other applicable departments.
  • Assist in Microbiology material inventory maintenance.
  • Assist in keeping all documentation current within the Microbiology Laboratory.
  • Assist in the coordination of batch manufacturing items with Operations and other applicable departments.
  • Assists in and drives achievements of departmental goals and commitments, regardless of obstacles.
  • Complete the appropriate training on cGMP, and demonstrate knowledge of the pharmaceutical industry expectations.
  • Assist in the performance and documentation for Cleaning Verification sample collection and analysis in compliance with Standard Operating Procedures and applicable Test Methods.
  • Aide in the maintenance of environmental monitoring trend data to drive continuous improvements and identify trends.
  • Provide support to facility to resolve nonconformance issues and identify corrective and preventative actions as related to environmental monitoring excursions.
  • Maintain GMP documentation relevant to the duties and responsibilities assigned.
  • Maintain laboratory instrumentation required for testing.
  • Assist in the review of test data and report any deviations to management.
  • Interact and coordinate activities with other departments and external vendors to support and meet the facility goals and objectives.
  • Participate in projects involving the Quality Control and/or Microbiology departments.
  • Handle and dispose of biohazard material in compliance with OSHA and Standard Operating Procedures.
  • Perform other related duties as required and assigned by Microbiology Management.

Qualifications

  • BS or greater in Biology or related sciences preferred.
  • Working knowledge and practical experience with good laboratory practices and competency with microbiology techniques such as Gram staining, isolation plating, aseptic practice, and microorganism identification methods.
  • Experience with common microbiology lab instrumentation is ideal, especially with autoclaves, light microscopes, and biohazard safety cabinets. 
  • Practical hands on experience with basic lab equipment such as pH meters, balances, water baths and other equipment common to microbiology methods.
  • Intermediate proficiency in MS Office (i.e. MS Word, MS Excel, Access, Outlook).
  • Must understand basic lab safety, bio-hazard and chemical waste disposal practices
       Back to Top

 

Project Management Associate

The Project Management Associate is responsible for assisting their assigned project manager(s) in the planning, execution, and client satisfaction of assigned projects.  

 

Primary Responsibilities

In collaboration with the project management team this role will assist with the following:

  • Coordinate project meetings
  • Coordinate client visits
  • Coordinate project timelines into global PM schedule
  • Prepare/edit project meeting minutes and presentations
  • Prepare project related shipment requests and controlled materials number requests
  • Ensures SharePoint BD and PM internal webpage is current with client visits, pertinent projects documents, etc.
  • Prepare/edit project scope changes
  • Monitor time tracking system for compliance
  • Assist in the roll=out of new department systems to harmonize Coldstream Project Management

Qualifications

  • Pharmaceutical industry experience (2 years preferred)
  • Project coordination/management experience (1-2 years preferred)
  • Experience with Microsoft Office required; Microsoft Project preferred
  • Bachelors degree
       Back to Top

 

Project Manager / Sr. Project Manager

The Project Manager is responsibility for facilitating and managing completion of all required elements of the project strategy. This includes elements from Business Development, Research and Development, Manufacturing/Operations, Quality, and Finance. The Project Manager works in collaboration with the project team and is responsible for assuring that the cross-fucntional team completes the identified tasks to successfully meet project objective.

Primary Responsibilities

  • Manage project scope, critical path, timeline and budget of multiple complex projects simultaneously.
  • Manage and communicate client needs and expectations to project team.
  • Coordinate with business development and/or client to ensure appropriate information and materials are provided to facilitate kick-off of project.
  • Create Project Tracker for projects and assist with maintenance.
  • Establish realistic timelines/goals with internal and external project teams.
  • Influence/motivate team members to execute project plans and achieve goals.
  • Manage project scope and ensure that adequate budgets are available.
  • Effectively schedule, facilitate and manage team meetings and ensure that proper communication regarding the project is appropriately elevated and distributed. 
  • Mentor team members and encourage positive team atmosphere.
  • Develop project risk management plan.
  • Establish and report on essential project metrics (such as variance) and elevate issues/risks to senior and executive management. Manage revenue forecast for projects.
  • Participate in revenue notification process and complete invoice notifications as required.
  • Lead projects in alignment with Coldstream Laboratories Procedures/Policies and FDA guidelines. 

 

Qualifications

  • Ability to work independently and make sound decisions.
  • Strong understanding of business strategy, finance, and operations management.
  • Good working knowledge of cGMP Guidelines and FDA regulations as well as an ability to understand company policies, SOPs, and Safety/OSHA policies.
  • Proficient in the use of common office software including MS Project (or equivalent alternate PM software), Excel, Word, and Power Point.
  • Sound understanding of project management practices; including project initiating, planning, execution, monitoring/controlling, and closeout.
  • Formal PM training required.
  • At least three years of previous pharmaceutical industry experience required, contract manufacturing or contract research organization experience preferred.
  • At least three years of Project Management experience required.
  • Bachelor’s Degree in applicable scientific field required, advanced degree preferred.
  • Master’s Degree in Business Administration preferred.
       Back to Top

 

Quality Assurance Specialist / Sr. Quality Assurance Specialist

Summary

The Quality Assurance Senior Specialist ensures complicance with regulations governing the manufacturing, testing, warehousing, and distribution of pharmaceutical drug products.  This position will help to further develop Coldstream's overall cGMP compliance and to support the day-to-day performance of cGMP compliance throughout the company.  The position will report directly to the Quality Assurance Manager.

Primary Responsibilities

  • Experience with conducting GMP investigations
  • Strong knowledge of GMP regulations, guidance, and general compliance expectations

Qualifications

  • Bachelor's degree in a scientifi discipline or equivalent with 5+ years relevant industry experience in a cGMP/FDA regulated environment with at least 3 years in QA
  • Good understanding of sterile manufacturing is required
  • Knowledge of cGMP and applicable FDA regulations
       Back to Top

 

Senior Validation Specialist

Summary

The Senior Validation Specialist reports directly to the Validation Supervisor and will perform specific assigned duties and undertake project work within the Validation Department.  

Primary Responsibilities

  • Write, schedule, plan, manage and execute validation and qualification protocols
  • of manufacturing, packaging, laboratory, utility systems and other equipment in accordance with 
  • current Good Manufacturing Practices (cGMPs), Good Engineering Practices (GEP) and change 
  • control. 
  • Directly interact with Coldstream Clients and regulatory agencies
  • Responsible for managing validation department in the absence of the Validation Supervisor
  • Responsible for reviewing executed qualification protocols and drafted documents by other Validation staff
  • Author summary reports for qualification protocols.
  • Act as technical interface between the company and 3rd parties for discussions surrounding the on-site validation activities.
  • Coordinate and interface with Operations, Technical Services, Facility Engineering, Microbiology, and Quality Assurance groups to assure successful project execution.
  • Lead qualification activities and timelines for equipment purchased for manufacturing purposes. Coordinate order timelines and equipment requirements with Technical Services group.
  • Represent validation at project team meetings and provide expert validation advice.
  • Perform routine duties as required in order to ensure the timely generation of accurate data and information.
  • Independently design, plan and manage own studies.
  • Maintain and develop state of the art knowledge applicable to existing and future validation processes and maintain up-to-date knowledge on regulatory expectations.
  • Lead investigations related to validation discrepancies and assure thoroughness of investigation, documentation and closure. Implement preventive/corrective actions as necessary.
  • Conduct periodic validation reviews of equipment, facilities, utilities, and sterilization cycles.
  • Author assigned Standard Operating Procedures (SOPs) for Validation department.

Qualifications

  • Bachelor’s degree in engineering or science required
  • Minimum of five years experience working in a GMP environment, with a minimum of three years of validation experience. 
  • Must have excellent technical writing skills and problem solving ability.
  • Sound knowledge, understanding, and application experience of quality management systems such as Deviations, CAPAs, Change Controls, etc.
  • Must be independent, detailed oriented, have the ability to manage own time, be flexible, tactful, and team oriented, balancing as appropriate.
  • Validation experience with manufacturing facilities/areas (e.g. multi-product facility, warehouse, cold rooms, autoclaves, depyrogenation ovens)
  • Strong computer and communications skills
       Back to Top