Overview
Quality Assurance (QA) Consultant/Auditor – Bioanalytical Laboratory Jobs in Redmond, WA at SystImmune
SUMMARY OF POSITION
Provide final disposition of finished material in adherence to cGMP’s Company Policies and procedures according to the product release lead-times. Coordinate product release of raw materials, packaging components and intermediates and maintain communication through the team with a planning approach. Responsible of assuring that all established controls to certify the Active Pharmaceutical Ingredient and Drug Products quality are implemented in the Manufacturing Operations. Is accountable for assuring that each production area follows their SOP’s based upon his/her findings. Plays an active role in identify and resolving Preventive and Corrective Action when needed to avoid potential quality issues. Receives general guidance from the QA Lead or QA Manager but handles routine matters independently. Provides support of compliance and regulatory aspects to other QA Department Areas and Production Personnel. The incumbent understands the internal and external customer’s business requirements and business process management.
PRIMARY RESPONSABILITIES
Audits the manufacturing, formulation, filling and/or packaging process documentation to assure adherence to cGMP’s, Company Policies and procedures.
Verify during spot checks walkthroughs that the operators use the correct ingredients in the right quantities. Verify that the batch records are being properly documented and that documentation is done by the operators in a timely manner. This includes verifying that the correct lot numbers are used and documented.
Leads and defines product release management with planning approach for current products and new projects, processes or initiatives as required by the site. Maintain communication through the team.
Performs final disposition, change status of raw materials, intermediates and finished material on SAP and physical in adherence to cGMP’s, Company Policies and procedures according to the product release lead-times.
Assures that all questionable material has been quarantined and/or rejected. Provides QA support to plant operations, including trouble shooting, to assist in resolving quality-related problems. Initiates the investigation process when required. Works with Production and other areas Supervisors and Operations Manager to find Root Causes and to develop preventive action.
Inform QO management of the status of operations and report unusual situations and/or problems. Maintains direct communication with other departments, such as Production, Technical Services and Procurement.
Evaluates and give follow-up to all process deviations and recommend further actions and provide support in the investigation of Deviation Systems and OOS Investigations by means of the ZENQMS or SAP Systems.
Develops and implement’s quality control procedures, reporting forms and any other necessary documentation required to minimize quality risk and cost to production across the site. Review/issuance of applicable procedures according to Quality Compliance manuals.
Provides support to regulatory and compliance issues, like complaint investigations, annual review preparation, internal, supplier or regulatory audits, etc. as required
Responsible to obtain and report site QA metrics according to the schedule.
Performs special projects as required and/or assigned by the QA Lead or QA Manager as well as participates in meeting associated with his/her area of responsibility.
Provides support in the training process to new auditors on departmental practices and procedures
Provide support to rotating shifts including weekends.
Comply with all environmental trainings, procedures, guidelines, practices, cGMP, permit conditions and internal notifications of any environmental event.
Perform any other job-related duties as required or that may arise in the future.
REQUIREMENTS
Education /Experience
Bachelor’s degree Biology, Chemistry, Microbiology, Industrial Chemical Process or Engineering.
Minimum 5 years’ experience in Pharmaceutical Industry and/or manufacturing environment or related field.
Strong understanding of cGMP’s and FDA mandated criteria for product release is essential and other applicable regulation
Licenses and/or Certifications
ASQC Certification as Certified Quality Auditor (CQA), preferred.
Technical Competencies
Fully bilingual (Spanish and English). Problem solving abilities, ability to train people and effective oral and written communications skills.
Risk Decision Making abilities
Knowledge on statistical samplings plans. Highly preferred with broad experience in analytical procedures, instrumentation’s, manufacturing practices and procedures.
Computer knowledge.
Knowledge of Federal Regulations such as cGMP’s, European and as applicable.
7. Self-starter and good communication skills. Ability to install confidence.
PHYSICAL DEMANDS
Able to move between areas such as Manufacturing, Packaging, Engineering, Utilities, Warehouse, among others.
Works under pressure
Willing to support other facilities
WORK ENVIROMENT
Able to move to different manufacturing areas including access-controlled areas.
Office and manufacturing areas
Job Type: Full-time
Pay: $55,400.00 – $94,200.00 per year
Benefits:
401(k) matching
Dental insurance
Health insurance
Life insurance
Schedule:
8 hour shift
Day shift
Monday to Friday
Night shift
Weekends as needed
Work Location: In person
Title: Quality Assurance (QA) Consultant/Auditor – Bioanalytical Laboratory
Company: SystImmune
Location: Redmond, WA
