Analytical QC Chemist (II-III)

CoreRx, a dynamic pharmaceutical technology company that empowers its employees with responsibility and offers a supportive and highly progressive work environment. At CoreRx you will find a challenging career path directed towards growth and opportunity. We employ talented, motivated people – team players who are innovative thinkers. We offer our employees a comprehensive, competitive program of benefits and a corporate culture based on core values that include innovation, a results-oriented focus, and ethical behavior.

There are multiple openings in our QC Department, depending on level of experience. Minimum requirements to qualify for Chemist II below:

EXPERIENCE AND EDUCATION REQUIREMENTS

• Minimum 3 years’ experience in a professional GMP pharmaceutical lab setting.
• Bachelor’s in Chemistry or related filed.
• HPLC and wet chemistry experience required.
• Must be fluent in English. (speaking, reading and writing)
• Experience with ELISA a plus!

RESPONSIBILITIES

The Analytical Chemist III also performs all essential job functions of Analytical Chemist I and II.

• • Designs, executes, and interprets complex procedures and protocols within a project or goal, subject to approval of supervisor.
  • Trains and directs lower level personnel.
  • Writes SOP’s and protocols.
  • Reduces literature references to practice.
  • Works independently on execution of complex procedures and methods
  • Demonstrates ability to accurately record and review laboratory documentation generated from developmental as well as established procedures.
  • Influences purchase of laboratory supplies as well as capital equipment.
  • Suggests alterations to procedures and protocols and studies. Compliant with safety and hazardous waste procedures.
  • Participates in moderate to extensive problem solving which requires original thought. Prepares reports with interpretation and can interpret the results of complex experiments.
  • Non-routine assignments. Designs experiments when requested. Handles major portion of project activity with supervision.
  • Performs routine as well as more complex assays and preparations.
  • Troubleshoots equipment, laboratory protocols and procedures.
  • Participates in audits for regulatory requirements.
  • Treats data with a high level of integrity and ethics.
  • Conscientious with safety procedures and knowledgeable of hazardous waste procedures.
  • Performs other related duties as assigned by management.

Job Type: Full-time

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.

Quality Assurance Inspector

CoreRx, a dynamic pharmaceutical technology company that empowers its employees with responsibility and offers a supportive and highly progressive work environment. At CoreRx you will find a challenging career path directed towards growth and opportunity. We employ talented, motivated people – team players who are innovative thinkers. We offer our employees a comprehensive, competitive program of benefits and a corporate culture based on core values that include innovation, a results-oriented focus, and ethical behavior.

EXPERIENCE AND EDUCATION REQUIREMENTS

• Minimum High School Diploma required /BS or BA preferred.
• Minimum 1 year of experience in Quality preferred
• 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..
• Prior Pharmaceutical GMP experience preferred.

The Quality Assurance Inspector works closely with Manufacturing to ensure quality performance.

RESPONSIBILITIES

• 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.

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

Laboratory Investigations Specialist

CoreRx, a dynamic pharmaceutical technology company that empowers its employees with responsibility and offers a supportive and highly progressive work environment. At CoreRx you will find a challenging career path directed towards growth and opportunity. We employ talented, motivated people – team players who are innovative thinkers. We offer our employees a comprehensive, competitive program of benefits and a corporate culture based on core values that include innovation, a results-oriented focus, and ethical behavior.

EXPERIENCE AND EDUCATION REQUIREMENTS

• Minimum BS/BA with a science or chemistry and biology background.
• Minimum 5 years’ experience in a professional GMP pharmaceutical lab setting and manufacturing facility.
• Prior experience with pharmaceutical laboratory investigations, incidents, and deviation.
• Solid technical writing skills
• SKILLS NEEDED
  • Required intermediate to advanced ETQ skills.
  • Ability to multi-task
  • Intermediate to advanced excel skills
  • Must be able to work with a high degree of accuracy
  • Knowledge of FDA guidelines on laboratory investigations and quality system

RESPONSIBILITIES

• Initiating laboratory investigations, incidents and deviations;
• Supervising execution, review and reporting of laboratory investigations, incidents and deviations
• Work closely with Analytical Management and QA regarding work needed for completing/closing the laboratory investigations, incidents and deviations according with the timeframes defined in the procedures.
• May recommend quality system improvements and provide advice on a laboratory investigations, incidents, and deviations.
• Performs other related duties as assigned by management.
• May serve of project teams.

ADDITIONAL QUALIFICATIONS:

Must have formal training in office procedures and use of office equipment. Must have the ability to communicate accurately and clearly both orally and in writing; pleasant telephone manner; able to think on feet when dealing with callers; customer service oriented can do approach to work. Ability to multitask and prioritize daily workload. Discretion and confidentiality.

Job Type: Full-time

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.

Senior Quality Assurance Specialist

LOCATION: SAN RAFAEL, CA 

CoreRx, a dynamic pharmaceutical technology company that empowers its employees with responsibility and offers a supportive and highly progressive work environment. At CoreRx you will find a challenging career path directed towards growth and opportunity. We employ talented, motivated people – team players who are innovative thinkers. We offer our employees a comprehensive, competitive program of benefits and a corporate culture based on core values that include innovation, a results-oriented focus, and ethical behavior.

EXPERIENCE AND EDUCATION REQUIREMENTS

• Minimum 7 years experience in the Pharmaceutical industry, including a minimum of 5 years of QA experience education requirements
• Minimum Bachelor’s Degree in Science (Master’s Degree is preferred)
• SKILLS NEEDED
  • Basic Knowledge of GMP Regulations (FDA, EU, JP)
  • Proficiency in MS Office applications; Word, Excel, Outlook
  • Strong organizational skills
  • Strong oral and written communication skills
  • Ability to multi-task

RESPONSIBILITIES

• The Senior Quality Assurance Specialist works collaboratively with other departments to mitigate and resolve potential quality issues by:
  • Review and approve investigations, incidents, CAPAs, and laboratory investigation reports
  • Lead, review, and approve complaint investigations
  • Tag materials under investigation
  • Lead, review, and approve rejection notices
  • Manage the training program
  • Assist in supplier and material qualifications
  • Participation in regulatory and client audits
  • Continuous improvement of the quality systems
  • Complies with all company policies, procedures, work instructions, and training requirements.
  • Collaboration with clients and suppliers on quality, regulatory, and technical issues
  • Contributes to the continuous improvement of the CoreRx Quality System
  • Ensures the CoreRx is in compliance with cGMP guidelines and ensures the staff is following CoreRx Quality policies and SOPs.
  • Ensures regulatory compliance
  • Other tasks as assigned.

  PHYSICAL DEMANDS

  • Sitting/standing 8 hours per day
  • Light lifting may be required on occasion.

  WORK ENVIRONMENT

  • General office setting

ADDITIONAL QUALIFICATIONS:

Must have formal training in office procedures and use of office equipment. Must have the ability to communicate accurately and clearly both orally and in writing; pleasant telephone manner; able to think on feet when dealing with callers; customer service oriented can do approach to work. Ability to multitask and prioritize daily workload. Discretion and confidentiality.

Job Type: Full-time

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.

Quality Assurance Specialist

Opening in our Clearwater, FL and San Rafael, CA locations.

CoreRx, a dynamic pharmaceutical technology company that empowers its employees with responsibility and offers a supportive and highly progressive work environment. At CoreRx you will find a challenging career path directed towards growth and opportunity. We employ talented, motivated people – team players who are innovative thinkers. We offer our employees a comprehensive, competitive program of benefits and a corporate culture based on core values that include innovation, a results-oriented focus, and ethical behavior.

EXPERIENCE AND EDUCATION REQUIREMENTS

• Minimum 3-5 years quality department experience in a GMP regulated industry
• Minimum BS/BA required

QUALIFICATIONS

• Proficiency in MS Office Applications; Word, Excel, Visio, Project, Access
• Strong organizational skills
• Proofreading skills
• 30 words per minute typing minimum

ROLE AND RESPONSIBILITIES

• Adherence to all company procedures
• Leading and writing investigation, deviation, CAPA and OOS reports
• Driving change control for system improvements
• Auditing documentation including but not limited to batch records, reports, and certificates
• Performing and participating in audits, cycle audits, vendor audits.
• Support of the document control systems.
• Review & Approve Deviation, CAPA, Issue Assessments
• Complaints/Adverse Events
• Administer Training Agenda/Curricula
• OOS Approval
• Monthly System Audits
• Tagging Material Under Deviation/Investigation
• Material determination if damaged upon arrival in Warehouse
• Administrator of X-Docs
• Submitting Supply Requests to Doc Control
• Add New Employees to X-Docs
• Metrics Report (All Inclusive – Deviations, CAPA, Rejections, Batch Review Errors, Lab Review etc…)
• Approval of Process Validation
• Phase II Investigations as required
• Audit Preparation for Health Authority Inspections/Customer Audits as requested
• Performs other related duties as assigned by management.

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