Reports to: Manager, Quality Assurance Position overview

The Manufacturing Quality Technician I will be and essential part of the business unit’s management team. This position will assist in management of the daily activities of the business unit, but will report independently to Quality Assurance (QA) management. The Manufacturing Quality Technician I will be responsible for providing direct QA support to the manufacturing shop floor. This role, with direct supervisory guidance, will be responsible for a diverse and challenging set of activities, all of which are related to setting and maintaining quality standards aligned with US FDA cGMP and other applicable international GMP regulations and guidance.

To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

Supervisory responsibilities

This position does not have supervisory responsibilities.

Essential job duties

• Perform routine observations of process operations for compliance with Master Batch Records (MBRs), including critical steps and 2nds check verifications. 
• Utilize problem solving techniques and demonstrate the ability to troubleshoot with limited supervision
• Recognize atypical data and report it to the appropriate supervisor or designee
• Work effectively with other departments, coworkers, and QA teams
• Review and audit shop floor records and reports such as logbooks and other types of documentation for completeness and accuracy
• Assist in identifying technical problems and provide guidance and support to real time shop floor quality issues up to and including: making real time product impact assessments and go, no go decisions with supervision
• Participate in quality systems implementation and maintenance efforts to ensure alignment with business process needs and user requirements
• Maintain awareness of changes impacting internal SOPs, recommend modifications for SOPs and author, review and edit documents, protocols, and problem reports
• Work with Quality Assurance to evaluate deviations related to production batches, the laboratories, or the facility
• Work with the QA Specialists to support customer issues, investigations, corrective actions and change controls

Education, experience, certification and licensures

• Associate's degree in science or related field, or 1-2 years experience in a technical role supporting industrial manufacturing quality programs. 
• Minimum 0-1 years’ related experience, preferably in a regulated manufacturing environment

Knowledge, skills and abilities

• Verbally express ideas, facts and proposals that are clear, logical, and concise
• Ability to read and interpret documents such as safety rules, operating and maintenance instructions and procedure manuals 
• Excellent verbal and written communication skills and ability to maintain inter-personal relationships
• Ability to apply basic math concepts
• Ability to apply common sense understanding to carry out instructions furnished in written, oral, or diagram form
• Proficient in the use of Microsoft Office applications
• Ability to adapt procedures to achieve company goals
• Ability to organize time in order to successfully manage multiple projects and priorities
• Ability to read, understand, interpret and implement technical writing and instructions
• Verbally expresses ideas and facts in a clear, logical and concise manner using acceptable grammatical style 
• Root cause analysis troubleshooting experience 
• Knowledge of batch manufacturing processing techniques 
• Ability to train and advise production personnel
• Ability to assess and review all regulated product-specific documentation
• Ability to use and apply critical thinking skills
• Ability to work 12 hours shift as assigned (day shift 8am - 8pm) (night shift 8pm 0 8am)

Physical requirements

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.

While performing the duties of this job, the employee is regularly required to talk or hear. The employee is frequently required to sit and use hands to finger, handle, or feel. The employee is occasionally required to stand; walk; reach with hands and arms; climb or balance and stoop, kneel, crouch, or crawl. The employee must regularly lift and /or move up to 10 pounds, frequently lift and/or move up to 25 pounds and occasionally lift and/or move up to 50 pounds. Specific vision abilities required by this job include close vision, distance vision, color vision, peripheral vision and depth perception.

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 moving mechanical parts; high, precarious places; fumes or airborne particles; toxic or caustic chemicals; risk of electrical shock; explosives; risk of radiation and vibration. The noise level in the work environment is usually moderate.

The above statements are intended to describe the general nature and level of work performed by people assigned to this classification. They are not intended to be construed as an exhaustive list of all job duties performed by the personnel as classified. Management reserves the right to revise or amend duties at any time.

All interested applicants must apply online. Please be aware of scammers. Curia will only send offer letters and requests for sensitive personal information from a curiaglobal.com email address. CURIA is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, or protected veteran status and will not be discriminated against on the basis of disability.