Quality Technician

Overview

Quality Technician

Who we are?

We are a French pharmaceutical industrial group, recognized for making affordable healthcare products that improve and simplify patients’ lives to as many people as possible.

With 30 years of technological expertise, we position ourselves as a world leader in sterile single dose with 10 sites on 4 continents and more than 2000 employees.

Since 2013, our site Unither Manufacturing LLC. based in Rochester (NY), specializes in the manufacture of Blow-Fill-Seal, Liquid Stick-Packs, Pharmaceutical bottles, Tablets and Capsules. It has more than 300 employees.

Reporting to the Quality Assurance Manager
,

As Quality Technician, you will help ensure and assist with site-specific quality compliance according to Standard Operating Procedures (SOPs) & specifications, quality review of batch records and other documents, label control, and assist with release activities and product inspections on the production lines. The on-the-floor quality team is responsible for making sure the process and documentation records are compliant with patient safety in mind.

Attention to detail is a must to be successful in this role.

We are currently seeking 2 Quality Technicians, one D-shift and one E - shift.

D - Shift

Hours:

Friday, Saturday, Sunday 11:00am - 11:00pm, 20% shift differential

E - Shift

Hours:

Friday, Saturday, Sunday 11:00pm - 11:00am, 25% shift differential

• Quality Technicians work with production operators completing inspections on the lines and completing batch record review.
• Verify that appropriate cleanings and line clearance have been performed.
• Verify differential pressures are within the limits.
• Verify labels and other quality checks in real time during production runs.
• Help lead investigations when deviations occur and support routine media fills on the BFS lines.
• Complete routine inspections of the production areas and be part of the internal audit team.

QUALIFICATIONS/

EXPERIENCE:

• High School Diploma/GED required. Bachelor’s degree in Chemistry, Biology, Pharmacy or related field, preferred.
• Must have 2-5 years working in an FDA regulated pharmaceutical or medical device manufacturing environment.

Standing 40% of the time. Walking 40% of the time. Sitting 20% of the time. Able to exert up to 10 pounds of force occasionally to lift, carry, push, pull or otherwise move objects.

Must be able to work safely with materials and equipment; works with chemicals, tools, and equipment. May work in an environment with variable but moderately high noise levels (hearing protection recommended). Must wear safety glasses, safety shoes, gloves, and other protective items as required. Must wear appropriate garments and coverings per cGMP (uniforms, hair/beard nets, etc.). Visual acuity necessary to perform activities such as: label inspection, component inspection, and ability to complete detailed review of documents.

The ability to write and communicate information via handwriting, telephone and computer keyboard.

Scope of decision making: Decisions require basic/routine analytical judgment. Plan and perform diversified duties requiring knowledge of a particular field and the use of a wide range of procedures. Involves the exercise of judgment in the analysis of facts or conditions regarding individual problems or transactions to determine what action should be taken within the guidelines or standard practice.

Level of supervision provided: Individual contributor, not responsible for the work of others.

Internal / external contacts: Regular inside and outside:
Requires contacts to carry out company policy and programs. Improper handling will have considerable effect on operating results. Must often deal with persons of substantially higher rank on matters requiring explanation, persuasion and obtaining approvals.

25.00 - 32.00

USD

The referenced compensation range represents the minimum and maximum compensation for this job. Individual annual salaries/hourly rates will be set within the job's compensation range, and will be determined by…