Career Opportunities

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

 


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

 

Analytical Scientist

Summary

The Analytical Scientist is responsible for the development and validation of analytical methodologies used in analytical laboratory.  In addition the Analytical Scientist performs analytical tasks using modern analytical pharmaceutical instrumentation (chromatographic, spectroscopic), or traditional physical and wet-chemical technique.  

Primary Responsibilities

  • Issue the New Product Assessment report to provide safety and cleaning information. 
  • Develop, establish, validate and transfer analytical methods as assigned.
  • Work with various analytical methods including cleaning verification, assay and impurities, dissolution, and residual solvents for API’s, in-process control, finished products, and excipients analysis.
  • Familiar with chromatographic (HPLC/GC) and spectroscopic technique
  • Perform physical and wet chemical methods verification if applicable.
  • Routinely discuss the status of assignments and potential problem with supervisor. 
  • Providing regular communication to internal and external customers via written reports and teleconferences.
  • Review, analyze data and information for technical correctness and accuracy, interpret and evaluate results properly.
  • Maintaining compliant documentation for all laboratory experimentation.
  • Submit complete experimental records for review.  Ensure data is filed and accessible for retrieve in accordance with applicable standard operating procedures.
  • Perform initial and stability testing for R&D lab batches and demonstration batches to support formulation development.
  • Perform laboratory instrumentation qualification, preventative maintenance, calibration and minor repair with proper documentation as needed.
  • Write and review Standard Operating Procedures, analytical deviations and laboratory investigations as needed.
  • Organize the workload and coordinate activities to carry out multiple projects concurrently and in accordance established objectives, timelines and deadlines.
  • Exhibit safety awareness and conduct laboratory operations and chemical disposal in a safe manner, maintain a clean and organized work environment.
  • Maintain familiar with current, relevant scientific literature and technologies.
  • Demonstrate a high level of professionalism, enthusiasm, dedication and productivity.

Qualifications

  • Bachelor’s degree, Master’s or PhD in chemistry, pharmaceutical sciences, or other related field.
  • At least 0-3 years of experience in pharmaceutical analytical development / quality control.  
                                                                                                                                                        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

 


Shipping and Receiving Clerk

Summary

Verify and maintain records on incoming and outgoing shipments. Prepare items for shipment. Duties include assembling, addressing, stamping, and shipping product or materials; receiving, unpacking, verifying and recording incoming products or materials; and arranging for the transportation of products and materials.  Staff will have use pallet jack, hand truck or forklift, general labor, and warehouse maintenance. Models and acts in accordance with our guiding principles and core values to ensure the shipment of orders to meet or exceed customer’s quality and satisfaction.

Primary Responsibilities

    • Scheduling and coordinating both domestic and international transactions with freight carriers and forwarders
    • Shipping of outbound product via bulk, van, air and rail transportation
    • Plans and optimizes efficient movement of goods in compliance with company policies and procedures
    • Oversee all logistic needs for multi-state facilities
    • This is a highly interactive position and may involve performing multiple tasks at once
    • Interact with warehouse personnel and truck drivers to ensure the right product is shipped to the correct locations in a timely manner
    • Coordinate shipping appointments with appointment scheduler
    • Communicate order changes to customer services/sales
    • Notify warehouse supervisor of situation that could result in a disruption to deliveries and customer services
    • Collate, prepare, distribute and process various bills of lading and shipping documents
    • Communicate clearly and concisely with employees of the organization
    • Supports and develops a team environment with overall focus on customer satisfaction
    • Ensures adherence to all quality, production, safety, and HR policies and procedures by all shipping employees
    • Ability to add, subtract, multiply and divide using units of U.S. currency, weight, volume and distance measurements
    • Handle periodic high pressure and tight deadlines as well as be able to adjust work schedule according to shipping needs
    • Individual must have a positive, calm and professional attitude while dealing with staff and customer’s in person, over the phone and by email
    • Ensure compliance with safety codes, policies, and procedures of the Company and standards established by OSHA
    • Performs any other assigned duty as directed by management

Qualifications

    • Candidates must be authorized to work permanently in the United States. Candidates must also be-able to read and write fluent English and have reliable transportation to and from work
    • High school diploma
    • Certification in DOT-Hazardous Materials in Transportation 49CFR parts 171-178
    • Hazardous Waste Management EPA RCRA
    • Hazmat Certification and ICAO and IATA/Dangerous Good Certification
    • Basic proficiency in Microsoft Offices, internet, web-based and job specific software applications
    • Accurate typing skills and/or data entry skills
    • Valid state issued driver’s license
    • Two+ years’ experience in warehouse environment
    • Ability to frequently lift and /or move up to 50 lbs.
    • Company Physical required
    • Willing to work multiple shifts 

Manufacturing Inspector and Labeler

Summary

Perform production activities including Equipment/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 (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 Inspectors.
  • Other duties as assigned by Manufacturing Team leader.

Qualifications

  • High school education or equivalent.
  • Minimum 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