Compliance/Regulatory Specialist

The Compliance/Regulatory Specialist ensures compliance with regulations governing the manufacturing, testing, warehousing, and distribution of pharmaceutical drug products. This position will support CLI’s overall cGMP compliance and the quality systems and regulatory compliance throughout the site. This position will report directly to the Associate Director, Compliance and Regulatory.

Primary Responsibilities

  • Ability to manage time and resources adequately for multiple projects.
  • Some experience with GMP investigations, including knowledge of: Root cause analysis, Risk assessment, Impact evaluation, Technical report writing.
  • Working knowledge of GMP regulations, guidance, and general compliance expectations
  • Ability to think analytically and assist with troubleshooting systemic GMP issues.
  • Provide support and coordination for compliance and regulatory-related projects.
  • Experience in a GMP manufacturing environment experience in (not all inclusive): Validation and change control, Supplier Quality Management, Quality System documentation review, Development and/or modification quality systems and other GMP processes, Auditing skills (internal, external/supplier), Client interactions (meetings, audits, investigations, etc.), Developing GMP/Compliance-based training for the department and CLI staff, Annual Product Review, Regulatory Filings (Support, Development, etc.), Development of GMP Compliance and/or Regulatory site policies and programs
  • Strong Computer Skills in Microsoft Word®, Excel®, Outlook®, and Web Browsers
  • Also desirable: Microsoft Access®, other GMP data management systems like electronic document management (EDMS), Trackwise, SAP, etc.

Qualifications

  • Knowledge of cGMP and applicable FDA regulations.
  • Bachelor’s degree in a scientific discipline or equivalent with 3+ years relevant industry
  • experience in a cGMP/FDA regulated environment (sterile manufacturing (injectables) preferred).
  • 4+ years of QA and/or Regulatory experience required (sterile manufacturing (injectables) preferred).
  • Knowledge of Common Technical Document (primarily Chemistry and Manufacturing Controls (CMC)) format, content, and filing requirements for US and EU. Other jurisdictions a plus.
  • Detail oriented team player with effective planning, organization, and execution skills.
  • Excellent communication skills with internal and external personnel essential.
  • Ability to work effectively at a fast pace with cross-functional departments and manage priorities to meet timelines.
  • Innovative, proactive, and resourceful; committed to continuous improvement.
  • Ability to anticipate and mitigate challenges.
  • Technical writing skills are required.
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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.
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Manufacturing Operator

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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Microbiology Technician

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
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Project Manager

Cross-functional 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 does not complete the tasks, but works in collaboration with the project team and is responsible for assuring that the team members from all disciplines are completing the identified tasks to successfully meet project objective. These responsibilities are carried through product/project lifecycle.

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 WorkZone Project Tracker for projects and assist with maintenance.
  • Establish practical, achievable, realistic timelines/goals with internal and external project teams.
  • Influence/motivate team members to enact project plans and achieve goals.
  • Identify scope creep and create scope change document with input from appropriate functional groups including business development.
  • Negotiate acceptance of scope changes with client.
  • Effectively schedule, facilitate and manage team meetings and ensure that proper communication regarding the project is appropriately elevated and distributed.
  • Coordinate with Finance to obtain project financials to hold project close-out meeting.
  • 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.
  • Assist in department standardization.
  • Assist in driving WorkZone utilization.
  • Provide WorkZone training to project team members as needed.
  • Other duties may be assigned to meet business needs.

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.
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Purchasing Agent

This individual will work closely with internal departments to coordinate the competing priorities for all projects across CLI. The Purchasing Agent/Buyer will be responsible for ordering and purchasing new supplies, ensuring successful delivery of materials, and coordinating the logistics to ship materials in a timely fashion. Able to manage multiple, complex bid negotiations and strategies at one time. Builds and maintains strong working relationships with internal customers and key suppliers. Provides a balanced focus on customer service and cost savings. Identifies and captures new savings opportunities.

Primary Responsibilities

  • Prepares specifications based on company’s needs and obtains competitive price quotes. Assists with the preparation and implementation of formal bids and negotiates procurement details with vendors; provides and coordinates product and service trial periods or demonstrations as required.
  • Assists departments in the evaluation of goods and services as needed.
  • Actively initiates price negotiation on MRO items.
  • Converts requisitions to purchase orders for approved vendors.
  • Compiles, analyzes and tracks metrics relating to cost savings, price structures as well as quality and delivery performance of suppliers and sub-contractors.
  • Resolves conflicts concerning materials or services at the department and vendor levels.
  • Keeps in constant contact with appropriate personnel to insure satisfactory operations.
  • Coordinates returns and/or repairs of products and monitors changes, modification, and technological advances that affect the purchasing of goods and services utilized by CLI’s plant and laboratories.
  • Works closely with staff on evaluating new suppliers, vendors or sub-contractors.
  • Sends out RFQ's annually to ensure most competitive costs are achieved and sets up annual contracts based on RFQ's.
  • Performs other related tasks, as required.

Qualifications

  • 5+ years Purchasing experience
  • Strong negotiation skills
  • Ability to analyze data
  • Bachelor’s degree
  • Experience with Microsoft Office
  • Competency in MRP/ERP preferred
  • Previous experience in the manufacturing industry required.
  • Previous experience in the pharmaceutical industry preferred.
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Quality Assurance Associate

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.
  • 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.
  • Provide support for the recall of non-conforming materials, investigations associated with product complaints, and product deviation reports.
  • 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.
  • Work directly with functional groups (as appropriate) to ensure that documentation is filing-ready including, but not limited to: investigations, verifications/validation, formulations, methods qualifications, and associated reports.
  • Will work extensively with warehouse staff on issues associated with material and finished product receiving, handling, storage, and disposition.
  • 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.
  • 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.
  • Minimum of 2 years progressive experience in a related regulated industry is required.
  • Must have good computer skills.
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Quality Assurance Specialist / Sr. Quality Assurance Specialist

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
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Sr. Validation Specialist

The Senior Validation Specialist reports directly to the Director of Quality Assurances and will perform specific assigned duties and undertake project work within the Process Technology Transfer and Validation Department. Ensures that company validation practices are compliant with cGMP regulations and meet industry standards.

Primary Responsibilities

  • Oversee the development, implementation and maintenance of validation master plans, validation procedures and other departmental documents.
  • Schedule, plan, manage and execute installation, operation and performance qualifications of manufacturing, packaging, laboratory, utility systems and equipment in accordance with current Good Manufacturing Practices (cGMPs), Good Engineering Practices (GEP) and change control. Will author related plans, protocols and summary reports.
  • Act as technical interface between the company and 3rd parties for discussions surrounding the on-site validation activities.
  • Coordinate and interface with Operations, Process Engineering, and Quality Assurance groups to assure successful project execution.
  • 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.
  • Represent the company at external seminars and supplier visits as required.
  • Manage the development of user requirement specifications (URS) and risk assessments for new equipment. Participate in equipment selection and manage factory acceptance testing for new equipment/systems.
  • 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.
  • Schedule, plan, manage and execute process validation studies. Author related plans, protocols and summary reports.
  • Author assigned Standard Operating Procedures (SOPs) to ensure compliance with Company policies and federal regulations.
  • Support regulatory submissions and regulatory agency inspections as required.

Qualifications

  • Bachelor’s degree in engineering or science required; Master’s degree preferable.
  • Minimum of three years’ experience working in a GMP environment, with a minimum of 1 – 2 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)
  • Risk Assessment/Management
  • Strong computer and communications skills.
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