QA Technician

College of American Pathologists; Vista (CA); On-site; USD 52,000 - 66,000; Full time

Job summary

CAPTEK is seeking a QA Technician to perform inspections and sampling during manufacturing, ensuring product conformance to specifications and adherence to cGMPs. You will monitor processes and support Operations while documenting outcomes.

You will help with line clearance, batch record reconciliation, and training of new inspectors, while upholding HACCP and food safety standards in a fast-paced work environment.

Qualifications

• 1–2 years of relevant work experience.
• Strong verbal and written communication.
• Ability to work independently and in a team.
• Attention to detail in a fast-paced environment.

Responsibilities

• Performs inspections, checks, tests, and sampling during manufacturing.
• Monitor manufacturing operations for cGMP compliance (housekeeping, hygiene, pest control, calibration, logbooks, batch records, signs and labels).
• Perform line clearance and approve readiness of workstations.
• Report non-conformances to Supervisor and recommend corrective actions.
• Review documentation to ensure accuracy and completeness.
• Provide proper bulk product labels.
• Perform reconciliation and closing of batch records.
• Assist management with inquiries and investigations.
• Assist in training new inspectors on documentation and inspection techniques.
• Adhere to HACCP and Food Safety.

Skills

Verbal and written communication

Teamwork and independence

Attention to detail

Organization skills

Ability to follow instructions

Punctuality and reliability

Education

High School Diploma or GED

Knowledge of cGMPs

Tools

Microsoft Word

Microsoft Excel

Outlook

Job description

Summary

It is the responsibility of the QA Technician to perform independent inspection functions to verify product conforms to specifications, to monitor processes and provide support to Operations, and to enforce cGMPs (Good Manufacturing Practices) and SOPs Standard Operating Procedures. The QA Technician assists management in identifying and reporting non-conformance issues and trends.

Essential Duties and Responsibilities:

• Performs and documents a wide variety of inspections, checks, tests, and sampling procedures during the manufacturing process.


• Monitor all aspects of the manufacturing operations to assure adherence to cGMP regulations which includes, but is not limited to: Housekeeping, Personnel and Hygienic Practices, Pest Control, Calibration and Scale Verification, Logbooks, Batch Records, Signs, and Labels.


• Perform line clearance for removal of all previous products, components, and foreign materials. Approve workstations for readiness prior to use.


• Report manufacturing operations non-conformances to Supervisor and recommend corrective actions.


• Review documentation to assure accuracy and completeness.


• Provide proper bulk product labels.


• Perform reconciliation and closing of batch records.


• Assist management in conducting inquiries and investigations.


• Assist in training new inspectors on proper documentation and inspection techniques.


• Perform other related duties as assigned by management.


• Adhere to HACCP (Hazard Analysis & Critical Control Point) and Food Safety.

Educational Qualification:

• High School Diploma or GED preferred


• Working knowledge of cGMPs


• General proficiency in using Microsoft Word, Excel, and Outlook

Required Skills / Experience:

• 1-2 yearsof relevant work experience required


• Good verbal and written communication


• Good interpersonal skills


• Ability to work independently and in a team environment


• Ability to follow instructions


• Good attendance and punctuality


• Good organizational skills/ attention to detail/ ability to work effectively in a fast-paced environment

Work Environment:

The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

While performing the duties of this job, the employee is occasionally exposed to work near moving mechanical parts, fumes or airborne particles and risk of electrical shock. The noise level in the work environment is usually moderate.

Physical Demands:

The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

The employee must occasionally lift and/or move up to 25 pounds. Specific vision abilities required by this job include close vision, peripheral vision, and the ability to adjust focus. While performing the duties of this job, the employee is occasionally required to stand, walk, sit, use hands to finger, handle, or feel; reach, climb, balance, stoop, kneel, crouch, talk and hear.

CAPTEK is an equal employment opportunity employer. In order to provide equal opportunities to all individuals, employment decisions will be based on merit, qualifications, and abilities, not on any mental or physical disability. We comply with the law regarding reasonable accommodation for disabled employees and applicants.

We do not discriminate on the basis of actual or perceived race, color, national origin, ancestry, sex (which includes pregnancy, childbirth, breastfeeding and medical conditions related to pregnancy, childbirth or breastfeeding), reproductive health decisions, gender, gender identity, gender expression, religious creed, disability (mental and physical) including HIV and AIDS, medical condition (cancer and genetic characteristics ), genetic information, age, marital status, sexual orientation, military and veteran status, or any other characteristic protected by federal, state or local law. Our management team is dedicated to this policy with respect to recruitment, hiring, placement, promotion, transfer, training, compensation, benefits, employee activities and general treatment during employment.