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.

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QA Associate

Summary

The Quality Assurance Associate will be responsible for the documented assurance that all functional groups are in compliance with current Good Manufacturing Practices (cGMPs) as described in the various regulations and standards defined by the CLI Quality Manual. 

Primary Responsibilities

  • Review and approve controlled documents requiring Quality Assurance approval signatures including, but not limited to: Nonconforming Material Reports, Calibration Records, Material Specifications, and Qualification Protocols.
  • Perform on-the-floor review of production documentation, including batch production records and supporting documentation, and provide GMP support (as appropriate) to production activities.
  • Must be able to independently perform the following functions: line clearances, disposition controlled materials and components, approve shipping requests, manage reserve program, and perform product inspections.
  • Assist in compliant event report investigations being conducted, resolved, and closed in a timely manner.
  • Assist in Quality Management Reviews and Annual Product Reviews, as appropriate.
  • Assist ongoing quality improvement processes with interdepartmental teams.
  • Assist in the development and review of departmental and other functional departments’ Standard Operating Procedures (SOPs), work instructions, etc.
  • Provide support for executed batch record and process simulation record review.
  • May assist the Quality Unit in regulatory activities that support product filings.
  • Assist with internal audits of CLI systems and departments.
  • May participate in client and CLI project meetings.
  • Provide support during customer and / or regulatory inspections and for responses associated with audit observations, as required.
  • May cross-train and provide support for other Quality Unit (Analytical Quality Control, Microbiology Quality Control, Document Systems, and Validation) as appropriate.
  • Other duties as required by organizational demands.

Qualifications

  • Preferred to have a minimum of a B.A. or B.S. in scientific field and/or equivalent degree.
  • 2 years progressive experience in a related regulated industry is preferred
  • Must have good computer skills.
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Shipping/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 
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AQC Data Reviewer

Summary

The Analytical Data Reviewer is responsible for reviewing and approving data that is generated by the analytical laboratory to ensure accuracy and compliance with Coldstream procedures and cGMP requirements.

Primary Responsibilities

  • Timely review of raw data, laboratory notebooks, reports and logbooks as necessary to support project throughput and laboratory compliance.
  • As needed, assist the department management with auditing of the laboratory workspace to ensure safety and compliance.
  • Continuously monitor general laboratory documentation practices to detect any undesirable trends or opportunities for improvements relating to quality and/or efficiency.

Qualifications

  • Bachelor's degree in Chemistry or other related field.
  • At least 3 years of pharmaceutical analytical development/validation laboratory experience.
  • Sound knowledge of USP, FDA, and ICH requirements and procedures.
  • Proficient in the use of Microsoft Word and Excel.
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