Manufacturing Technician

RESPONSIBILITIES  

• Works cross functionally within the organization to facilitate the successful completion of all development projects and meets the objectives and goals of CoreRx Inc.
• Leads manufacturing projects applicable to the individual’s qualifications.
• Performs batch instructions to include dispensing of materials, operation of all minor and some major process/blending equipment.
• Perform physical testing, product inspection, packaging, and general support of the manufacturing operation.
• Perform cleaning, equipment assembly/set-up and documents entry activities
• Perform preventative maintenance, calibrations, repairs to equipment, set-up and daily checks to support the manufacturing operation.
• Supports process and facility operations complying with CoreRx Inc. and FDA, GMP requirements
• Room cleaning, equipment cleaning and storage of related parts and equipment cleaning verification.
• Training on SOP’s to remain current for job requirements, logbook entries and GMP documentation.
• Author/review SOP’s and execute qualification protocols.
• Ability to comprehend and follow written instructions.
• Performs other related duties as assigned by management.

WORK EXPERIENCE REQUIREMENTS

• 1-3 years’ experience preferred in a cGMP pharmaceutical manufacturing environment.
• Experience preferred in manufacturing, production, machine operator or technician, batch records, tablets, tablet compression, solid dosage, powder, sachets, pouches, SOPs, GMP and FDA.
• Must be able to understand written and verbal directions in English.

EDUCATION REQUIREMENT

• High School Diploma/GED required.
• Must be able to speak clearly, read, write and understand the English language.

PHYSICAL DEMANDS

• Able to stand for long periods of time.
• Able to lift 55 lbs.
• Able to see/hear and communicate effectively.

WORK ENVIRONMENT

• Will work in a climate-controlled environment.
• Will wear the proper protective equipment for a manufacturing environment.

Quality Assurance Inspector

• Adherence to all company procedures/SOP’s (Standard Operating Procedures)
• Perform sampling of in-process and raw materials
• Release of materials
• Participating in the environmental monitoring and water systems
• Perform cleaning verifications
• Inspections on Labels / Components (Printing and Filling out TM-0210 pages for all inspections or Lab Notebook)
• Perform and review In-Process Checks
• Tagging Released Materials in Warehouse (Green Release Tag and Component Inventory Cards)
• Release Staged Batches to GMP from Warehouse
• QA Retain Storage and update location in Database
• Deliver samples to Analytical / Formulations / Project Management
• Major/Minor Clean Room Releases for Manufacturing
• Adhoc Inspections as they arise (i.e. Complaints or special requests)
• Working on Sampling Statistical Form to use for visual capsule defects
• Equipment Cleaning Verification and Validation Sampling
• Preparing and Shipping samples directly to contract laboratory when required
• Review & Approve In House Release Testing performed by QA Inspectors
• Fill out Green Release Tags for any approved In-House Release testing performed by QAI
• Performs other related duties as assigned by management.

WORK EXPERIENCE REQUIREMENTS

• Proficiency in MS Office Applications; Word, Excel
• Strong organizational skills
• Proofreading skills
• Ability to communicate clearly with colleagues and clients in written and verbal form.

EDUCATION REQUIREMENTS

• High School Diploma
• BS or BA preferred

Senior Process Engineer

The Senior Process Engineer develops, configures and optimizes industrial processes from inception through to start up and certification. Assesses processes, takes measures and interprets data. Designing, running, testing and upgrading systems and processes.

RESPONSIBILITIES  

• Create and execute protocols for Scale up, Optimization Studies, Process Validation and Cleaning Validation. Develop all documentation for process validations including IQ, OQ, and PQ protocols as well as risk assessments.
• Create Manufacturing Batch Records for developmental, clinical, registration and commercial products.
• Create/revise existing/new SOP’s for equipment and processes.
• Lead/support technology transfer projects.  This includes working directly with R&D teams/personnel for the transfer of data, processes and technical specifications for implementation into large scale manufacturing operations.
• Analyze data, present/write technical reports and develop design of experiments for new product implementation.
• Investigate opportunities for improvement within departments looking specifically to increase accuracy and efficiency.  This will encompass workflow evaluations as well as equipment evaluations.
• Provide technical assistance/expertise to maintenance and operations personnel on equipment troubleshooting and repairs.
• Assist in training Manufacturing personnel.
• Author manufacturing deviations and CAPA.
• Assist in creation of technical risk assessments.
• Perform process capability analysis on production processes.
• Implement Lean Manufacturing Principles in Production area.
• Assist in gap analysis, FMEA and/or risk assessments to ensure evaluation of critical systems and equipment comply with all regulatory requirements, e.g., cGMPs, FDA Guidelines, USP, ISPE, ISO etc.
• Interacts with the regulatory officials to convey the compliance level of the equipment and facility during regulatory inspections.
• Strong problem solving, technical writing and statistical analysis skills.
• Exhibits strong process and equipment design skills.
• Manages projects to deliver results on time and on budget.
• Proficient in Process Safety concepts and methodology.
• Proficient in Commissioning and Validation strategies and execution.
• Focused on Meeting Customer Needs.
• Ability to communicate clearly with colleagues and clients in both written and verbal form.
• Performs other related duties as assigned by management.

WORK EXPERIENCE REQUIREMENTS

• Must have 10+ years Pharmaceutical experience, preferably in a process engineering role.
• Must have experience in solid dose formulations.
• cGMP and validation experience preferred.

EDUCATION REQUIREMENT

• BS degree in Engineering or Sciences.

Senior Scientist

Performs all essential functions of Analytical Chemist III.

• Expected to be the lead scientist for designated projects, to include direct client communications and attendance at project team meetings and teleconferences; ability to make autonomous decisions regarding day to day activities.
• Demonstrates ability to independently manage design/development, optimization, validation and transfer of analytical methods in support of Drug Substances and Drug products.
• Provides analytical services to manufacturing, process development, validation, new material and critical reagent qualifications. All activities are performed in accordance with specifications, standard operating procedures, approved test methods and/or protocols, and regulatory requirements.
• Analysis of finished products, in-process materials, raw materials, and cleaning verification/validation samples according to the assigned specifications, methods and protocols. Analytical instrumentation may include, but is not limited to HPLC, GC, TOC Analyzer and Spectrophotometer.
• Demonstrates ability to prioritize assignments; time management and multitasking in a dynamic environment.
• Documents all experiments and results thoroughly with detailed observations.
• Exercises technical discretion in the design, execution and interpretation of experiments that contribute to project strategies and goals.
• Critically assesses experimental data and provides interpretation of results, including statistical analysis.
• Prepares technical reports, summaries and protocols.
• Utilizes independent action and decision making with follow-up reporting to supervision.
• Directs and executes experiments of a scientifically complex nature.
• Demonstrates ability to interact effectively within department team, mentoring and training unit personnel as needed.
• Appreciates and values different perspectives. By example, often motivates co-workers and peers to perform their best work.
• Evidence of effective communication, both verbally and written, highly organized, analytical, accurate, and detail-oriented.
• Demonstrates ability to work successfully in a highly collaborative, team oriented, customer focused environment.
• Responsible for the preparation of robust processes that lead to the development of new technologies that support specific client platforms.
• Provide support for operations and other process support teams by providing scientifically sound recommendations, improving efficiency, meeting of timelines, and the development of successful processes while operating in compliance with cGMP regulations, and company SOPs.
• Performs other related duties as assigned by management.

WORK EXPERIENCE REQUIREMENTS

• Minimum of 5 years’ experience with identification or separation techniques such as HPLC, UPLC, GC, and experience with method development and/or validation

EDUCATION REQUIREMENTS

• Doctorate in scientific field with 3-years’ experience, or MS in scientific field with 5-years’ experience, or BS in scientific field with 10-years’ experience in an analytical environment.

PHYSICAL DEMANDS

• Able to stand, sit for long periods of time.
• Able to read, write, speak and comprehend the English language.

Validation Engineer II

RESPONSIBILITIES

Validation Engineers provide support for validation/qualification initiatives to internal project teams and ensure project schedules are met with an emphasis on building, room, utility, equipment, and computer system validations; ensure that CoreRx systems are in compliance with regulatory requirements; author, assess, maintain, and review validation and qualification lifecycle documentation.Areas of responsibility for the Validation Engineer II include:

• Author validation documentation including user requirements, functional requirements, and design requirements, validation summary reports and test protocols for installation, operation, and performance of facilities, equipment and software.
• Direct and perform the execution of validation protocols.
• Development and modification of Standard Operating Procedures (SOPs) and Forms for equipment and systems.
• Work with third-party suppliers, subcontractors, and customers on validation projects.
• Aid in the improvement of validation systems, documents, procedures, and tools.
• Ability to work efficiently and independently with some guidance.
• Very analytical and detail oriented.
• Works in a neat, orderly, and safe manner, constantly seeking to improve methods and the safety of others.
• Other duties as assigned.

WORK EXPERIENCE AND REQUIREMENTS

• 3 – 7 years of validation experience in a FDA-regulated industry (preferably pharmaceutical).
• Thorough knowledge of FDA/ISO/GMP requirements
• Excellent written and oral communications skills with a strong emphasis on organizational capabilities.
• Demonstrated flexibility in carrying out varied assignments in a high-quality work environment.
• Demonstrated proficiency in computer skills as a business tool, specific work experience using Microsoft applications (Word, Excel, PowerPoint).

EDUCATION REQUIREMENTS

• BS in an Engineering or Scientific Discipline, Business, or a related field preferred.  Experience in lieu of education will be considered.

Accounts Payable Coordinator

This is a great opportunity for a recent grad or for someone who wants to build a foundation in accounting. Bring your desire to learn and practice your skills in all aspects of accounting. Individual must be a highly motivated self-starter that is capable of working on various initiatives in a high volume fast-paced environment.

RESPONSIBILITIES

• Provides support to the accounts payable department and performs accounts payable functions.
• Processes invoices for payment; prints and mails accounts payable checks.
• Enters and tracks purchase orders.
• Performs data entry and spreadsheet management for PTO.
• AP vendor invoice entries.
• Maintains accounts payable files and records.
• Responds to employee inquiries regarding time and attendance.
• Assists with preparation of 1099s.
• Assists with monthly closings.
• Assists with related special projects as needed.

WORK REQUIREMENTS

• 10-key by touch.
• Demonstrated ability to calculate figures and amounts.
• Acute attention to detail.
• Strong organizational skills.
• Must have a sense of urgency to meet deadlines accurately.
• Commitment to excellence and high standards.
• Excellent written and verbal communication skills.
• Ability to understand and follow written and verbal instructions in English.
• Versatility, flexibility, and a willingness to work within constantly changing priorities with enthusiasm.

EDUCATION REQUIREMENTS
Associates Degree or 6 months to one years of related experience, or equivalent combination of education and experience.

PHYSICAL DEMANDS

• Occasionally/Frequently required to stand.
• Occasionally/Frequently required to walk.
• Frequently/Continually required to sit.
• Frequently/Continually required to utilize hand and finger dexterity.
• Frequently/Continually required to talk or hear.
• Frequently/Continually utilize visual acuity to operate equipment, read technical information, and/or use a keyboard

WORK ENVIRONMENT

• Office Environment

Notification to Agencies:
Please note that CoreRx Inc. does not accept unsolicited resumes from recruiters or employment agencies. In the absence of a signed Master Service Agreement, and specific approval to submit resumes to an approved requisition, CoreRx Inc. will not consider or approve payment regarding recruiter fees or referral compensations.

Job Type: Full-time

Staff Accountant

The Staff Accountant computes and prepares data for journal entries, general ledger, and related financial statements; performs day-to-day general accounting functions.

RESPONSIBILITIES

• Prepares general ledger journal entries, fixed asset tracking, monthly balance sheet reconciliation, and bank reconciliation.
• Generates and files monthly financial reports.
• Develops, analyzes, and prepares periodic financial statements for timely distribution to management.
• Work with CFO to develop and implement standard costing system, develop overhead rates, basis pools and track production variances.
• Assists with accounts payable functions including but not limited to verifying invoices, expense reports, check requests, and purchase requisitions; entering data into accounts payable system; and processing weekly check runs.
• Assists with accounts receivable functions including but not limited to applying payments to appropriate accounts, monthly invoicing, reconciling customer accounts, and handling customer inquiries.
• Reconciles petty cash fund.
• Assists with budget preparation.
• Prepares and analyzes monthly journals.
• Performs daily banking procedures.
• Maintains fixed asset and related depreciation schedules.
• Prepares monthly tax returns.
• Assists with annual external audits.
• Analyzes and reconciles general ledger accounts.
• Prepares account analyses and reconciliation.
• Coordinates implementation of accounting systems and accounting control procedures.
• Reviews and analyzes the organization’s accounting operation; recommends improvements.
• Assists with related special projects as required.
• Performs other duties as assigned by manager.

WORK EXPERIENCE REQUIREMENTS

• Proficient in Micro Soft AX 365 suite or equivalent ERP System. Knowledge of QuickBooks accounting system. Office suite to include excel, word, power point and outlook.
• Cost Accounting experience in a manufacturing setting utilizing a standard cost system. Pharmaceutical Industry or Pharmaceutical Contract Services experience a plus.
• Ability to prepare reports and business correspondence.
• Demonstrated ability to calculate figures and amounts such as discounts, interest, commissions, and percentages.
• Commitment to excellence and high standards.
• Excellent written and verbal communication skills.
• Ability to understand and follow written and verbal instructions
• Strong organizational, problem-solving, and analytical skills; able to manage priorities and workflow.
• Ability to work independently and as a member of various teams and committees.
• Versatility, flexibility, and a willingness to work within constantly changing priorities with enthusiasm.

EDUCATION REQUIREMENTS

• Minimum of four-year Accounting, Finance or Economics degree from college or university, three to four years related experience, or equivalent combination of education and experience.
• CPA track a plus

PHYSICAL DEMANDS

• Occasionally required to stand
• Occasionally required to walk
• Frequently/Continually required to sit
• Frequently/Continually required to utilize hand and finger dexterity
• Frequently/Continually required to talk or hear
• Frequently/Continually utilize visual acuity to operate equipment, read
• technical information, and/or use a keyboard

WORK ENVIRONMENT

• Office environment
• Occasional visits to the production floor in a cGMP pharmaceutical production environment.

Notification to Agencies:
Please note that CoreRx Inc. does not accept unsolicited resumes from recruiters or employment agencies. In the absence of a signed Master Service Agreement, and specific approval to submit resumes to an approved requisition, CoreRx Inc. will not consider or approve payment regarding recruiter fees or referral compensations.

Job Type: Full-time

Facilities Technician

Facilities Technicians are responsible for a variety of semi-skilled and skilled day-to-day facility operations, the scheduled, unscheduled and preventative maintenance and repair of a wide variety of facility systems and manufacturing equipment, and require a strong mechanical skill base to include but not limited to: HVAC, compressed air components and systems, generators, building management systems, control logic systems, security systems, water conditioning systems, electrical, lighting, fenestration, plumbing, drywall, and general landscape maintenance.

RESPONSIBILITIES

• Perform scheduled, unscheduled and preventative maintenance on, but not limited to: HVAC, generators, water conditioning systems, manufacturing equipment, and compressed air systems.
• Perform installation and repair projects as scheduled or assigned, involving, but not limited to: plumbing, drywall, lighting fixtures, carpentry, fenestration, furniture, floors, and painting.
• Maintain cleanliness and appearance of the internal and external building and grounds. • Prepare for company event set-ups, employee moves, and workstation modifications or relocation.
• Perform tasks that may involve the use of ladders, measuring equipment, and hand or powered tools.
• May oversee basic contracted facility services.
• May assist in or provide basic knowledge for the recommendation of purchase, cost saving measures, and development of a project or repair project.
• Maintain logbooks, work orders, and maintenance documents. Perform other duties as assigned by manager. Works in a neat, orderly, and safe manner, constantly seeking to improve methods and the safety of others. Ensure safety procedures are followed. Maintain a safe and clean work environment for employees while performing required duties. Work within a work schedule designed to minimize the impact on manufacturing and other critical operations. Works under general supervision.

WORK EXPERIENCE REQUIREMENTS

• Basic knowledge of hand and power tools, and measuring equipment.
• Ability to read and understand compressed air, electrical wiring and control diagrams.
• Knowledge of safety and environmental rules and regulations concerning procedures, tools, mechanical and electrified equipment, commonly used chemicals and basic safe work practices is required.
• Must possess a welcoming manner and positive attitude; demonstrate effective communication skills; ability to professionally interact with guests and other employees; and assist in handling customer work orders, involving management as necessary.
• Must be able to communicate clearly and effectively in English both verbally and in writing.

EDUCATION REQUIREMENTS

• High school diploma or GED and one or more (1+) years of building maintenance experience, or any equivalent combination of training and experience.
• Basic use of a laptop/personal computer and computer skills.
• Must possess basic math and reading skills.

PHYSICAL DEMANDS

• Standing, walking, kneeling, crawling, crouching and bending approximately 75% of the day.
• Ability to lift and carry up to 50 pounds.

WORK ENVIRONMENT

• Capable of working indoors or outdoors in hot or cold temperatures

Notification to Agencies:
Please note that CoreRx Inc. does not accept unsolicited resumes from recruiters or employment agencies. In the absence of a signed Master Service Agreement, and specific approval to submit resumes to an approved requisition, CoreRx Inc. will not consider or approve payment regarding recruiter fees or referral compensations.

Job Type: Full-time