Quality Validation Tech

McGuff Pharmaceuticals, Inc.; Santa Ana (CA); On-site; USD 65,000 - 90,000; Full time

Job summary

McGuff Pharmaceuticals, Inc. in Santa Ana, CA is seeking a Pharmaceutical Quality/Validation Technician to join Quality Engineering and Validation.

You will plan, organize and perform commissioning, qualification and validation for processes, facilities, equipment and controls, and maintain the requalification program. The role includes IQ/OQ/PQ, PPQ, sterile processing validation, environmental monitoring and process improvements to meet cGMP standards.

Qualifications

• 2 year technical degree required; BA/BS a plus.
• Experience in pharmaceutical/biotech, especially sterile injectable manufacturing.
• Proficient with computer software and data systems; GMP knowledge required.
• Good written and verbal communication; ability to work independently and in a team.
• Knowledge of ISO 9000 is a plus.

Responsibilities

• Maintain and execute qualification/validation protocols (IQ/OQ/PQ).
• Plan, coordinate and perform validation for processes, equipment and facilities.
• Support requalification program and documentation of validation activities.
• Develop SOPs and participate in risk analyses as assigned.
• Ensure compliance with cGMP and project-specific requirements.

Skills

Communication skills

Independent work

Team player

Multitasking

Typing

Statistical techniques

Education

Two-year technical degree

Bachelor's degree preferred

Tools

Kaye Validator

Microsoft Office Professional

Job description

McGuff Pharmaceuticals, Inc. in Santa Ana, CA is looking for a Pharmaceutical Quality/Validation Technician in Santa Ana, CA.

The Quality/Validation Technician (QVT) will work closely with the Quality Engineering and Validation Supervisor to plan, organize and perform commissioning, qualification and validation for defined processes, facilities, equipment and process controls that meet McGuff Pharmaceutical’s high standards. The Technician will maintain the existing manufacturing facilities by primarily maintaining the requalification program.

The QVT will develop, plan, coordinate and execute qualification projects associated with drug product sterile contract manufacturing, aseptic processing, filling, and packaging. The Technician shall be familiar with the qualification of facilities, pharmaceutical manufacturing equipment/systems, sterilization processes, sterile filling processes, cleaning processes, environmental room monitoring, media fills, and process validation runs. The Technician will be capable of executing equipment IQ/OQ/PQ and process validations as required. In addition, the Technician will also assist, in a team based approach, the development and improvement of processes to ensure such processes meet McGuff Pharmaceutical’s high standards of process capability, reliability, and repeatability.

The Technician will be capable of coordinating and executing process validations and associated system operational needs including, but not limited to, equipment and computer system Installation and Operation Qualifications (IQ/OQ) including temperature mapping, Performance Qualification (PQ) of Utilities, Sterilization and Decontamination Systems, Process Performance Qualification (PPQ), and full process validation documentation. Duties may also include assisting with and evaluating specification development, equipment procurement, operation and maintenance procedure development, and qualifying raw materials, in-process materials and finished goods, as required. The Technician shall ensure McGuff processes are compliant with cGMP requirements.

Essential functions and duties shall include:

• Maintain the validation program for computer systems, facilities, equipment, manufacturing processes in an aseptic filling facility by coordinating, performing and scheduling requalifications and periodic reviews per the validation program.
• Develop and document written qualification/validation protocols and reports.
• Perform and assist with qualification / validation protocols for projects in compliance with McGuff policies and procedures and industry guidelines in the performance of, such as, IQ/OQ/PQ and other validation activities.
• Familiarization of testing procedures as needed for process inputs, outputs and parameters, such as, temperature monitoring, TOC analysis, LAL (Endotoxin), environmental monitoring, bioburden testing, sterility testing, chemical analysis, physical analysis, etc. according to written procedures (SOPs).
• Develop and document written SOPs, as required, for current Good Manufacturing Practices (cGMP).
• Implement document changes and control procedures.
• Conduct QA investigations and follow-up
• Prepare and document procedures and protocols, including commercial batch record preparation and review.
• Participate in Risk Analysis (FMECA’s), as assigned
• Assist with process development for targeted products (under a team approach to product/process development).
• Qualification and review of maintenance procedures and schedules for process equipment troubleshooting and corrective action of processing deviations
• Other related duties as assigned.

Minimum qualifications shall include:

• 2 year technical degree required. Bachelor’s degree (B.A./B.S.) of Science in Engineering, Chemistry or related field or equivalent is a plus.
• Prefer minimum of 1-2 years relevant Pharmaceutical/Biotechnology Industry experience with a portion of that experience in manufacturing of sterile injectable drugs via aseptic processing.
• Proficient with computers and related software (Microsoft Office Professional)
• Familiarity with related GMP procedures and requirements. Including knowledge of appropriate Quality Systems and cGMP requirements (FDA, EU, ICH) with the ability to assess compliance risks.
• Familiar with data acquisition systems and protocols. Prefer proficiency with specific data acquisitions systems such as Kaye Validator.
• Versed in the proper use of statistical techniques and sampling plans.
• Typing and office based skills
• Excellent oral and written communication skills.
• Ability to work independently and as a team member.
• Ability to manage multiple concurrent tasks / studies.
• High energy, enthusiastic self-starter who can work with minimal supervision.
• Well organized and detail oriented.
• Prefer working knowledge of ISO 9000 requirements.

What will be expected of you:

• Acquire knowledge of and assure compliance to corporate policies and procedures.
• Ability to work with others.
• Possess excellent communication skills.
• Work with all McGuff employees to foster and promote quality.
• High regard for Trust, Integrity, Honesty, Ethics, Innovations and Safety in self and others.
• High sense of Responsibility, Ownership, Accountability.
• Capable of Flexibility in work requirements/conditions and willingness to embrace change.
• Results driven and a hands on approach to completion of assigned tasks.
• Comply with all McGuff Policies and Procedures.

Physical requirements:

• Position requires bending, squatting, climbing, and reaching above shoulder level. You must be able to comfortably be able to do so.
• Position requires sitting, standing, walking, handling and manipulating objects (manual dexterity and fine finger movement).
• Position will require repetitively lifting/carrying up to 50 pounds.
• In addition to the minimum requirements, the preferred candidate will have experience in the pharmaceutical manufacturing industry (aseptic fill, small volume, sterile, injectable products), and experience in technical presentations and report writing.