Overview

Associate Director GMP Quality Jobs in Boston, MA at Olema Oncology

Job Purpose: The Quality Technician will perform quality control checks at various stages of the production process. He/she will compile and evaluate statistical data to validate products and process conformance to meet internal and external customer requirements. If this description matches your skillset, we encourage you to apply!

Essential Job Functions:

Interprets engineering drawings, specifications, and control plans and instructions that align with management, engineering, and operations to validate product quality.
Conducts walk-abouts on the shop floor to test products at specified stages in production, including receiving, in-process, and final inspection as needed.
Manage MRB hold area and present weekly status updates via email or in-person meetings.
Ensure conformance with quality standards. Basic understanding of ISO 9001:2015 standards.
The ability to identify deviations from known standards and take appropriate action.
Complete all required records and paperwork to include inspection reports, return reports, etc.
Follow all company policies and procedures as applicable to this position.
Follow all clean-up and housekeeping procedures (5S)
Understand and follow health, safety, security, quality, and environmental practices as required for IATF, 19649/ISO 9001:2015

Non-Essential Job Functions:

Travel may be required
Other tasks, duties, and responsibilities as requested by the QA Manager or other member of management

Qualifications:

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

Education and/or Experience:

Must be 18 years of age of older
Requires a high school diploma, or equivalent
ASQ Certification preferred
CMM operation experience preferred
2 years of related manufacturing experience

Abilities, Skills and Knowledge

Ability to establish and maintain effective working relationships with co-workers.
Ability to use measuring instruments, (micrometers, calipers) test sets, and gauging equipment
Problem-solver mentality
Ability to read customer drawings and specifications. Basic knowledge of GD&T.
Ability to read and comprehend basic instructions.
Ability to perform basic math functions of addition, subtraction, multiplication, and division
Ability to calculate figures and amounts such as dimensions, tolerance, etc.
Ability to operate Windows and/or Apple based computers and working knowledge of typical office programs – i.e. Microsoft Outlook, Word, Excel, and PowerPoint.
Knowledge of hand tools.
Knowledge of Quality Standards.
Knowledge of inspection equipment and techniques.
Require a fundamental knowledge of machine shop operations acquired by on-the-job training.

Physical Demands

Frequently required to walk, talk and hear.
Occasionally required to sit
Occasionally required to reach above shoulders, climb or balance; and stoop, kneel, or crouch
Lift and/or move up to 50 pounds.
Regularly required to use hands to finger, handle, or touch objects, tools, or controls

Training Requirements

Training requirements as applicable to the Quality Management System and Environmental Management System

Work Environment:

Primary work is performed in manufacturing area
Noise level in the work environment is usually loud

Protective Equipment Required:

Steel-toed work shoes.
Ear plugs
Safety glasses with side shields

NOTE: This job description is not intended to be all-inclusive. Employee may perform other related duties as negotiated to meet the ongoing needs of the organization.

Job Type: Full-time

Pay: $20.00 – $25.00 per hour

Schedule:

Day shift

People with a criminal record are encouraged to apply

Ability to Relocate:

Sussex, WI: Relocate before starting work (Required)

Work Location: In person

Title: Associate Director GMP Quality

Company: Olema Oncology

Location: Boston, MA

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