Manufacturing Quality Associate- 2nd Shift M/F (28127)

At Guerbet, we build lasting relationships so that we enable people to live better.

We are a global leader in medical imaging, offering an extensive portfolio of pharmaceuticals, medical devices, as well as digital and AI solutions for diagnostic and interventional imaging. As a pioneer in the field of contrast products for the last 95 years, we continuously innovate.

Achieve, Cooperate, Care, and Innovate are the values that we share and practice.

For more information on Guerbet, go to www.guerbet.com and follow Guerbet on Linkedin, Twitter, Instagram and Youtube.

WHAT WE'RE LOOKING FOR:

The Manufacturing Support for QA (also known as IPQE internally) is a specialized role responsible for monitoring formulation, filling, sterilization, and packaging operations for compliance to site SOPs and cGMP including timely review of cGMP documentation at designated, critical, process points. Monitors the production/packaging areas for compliance. Inspects product samples to ensure compliance to Covidien requirements. Participates in containment, recovery, issue escalation process, and corrective actions involving atypical quality events. Writes OOS and minor investigations. Supports team members to insure all sampling is accomplished in a timely manner and any defect related issues are addressed. Supports site and departmental initiatives. The position routinely interfaces with various personnel from Formulation, Filling, Sterilization, Packaging, Laboratories, Facilities and QA. This position is on 2nd shift, 1pm - 9:30pm (shift start time may vary) M- F with occasional rotating weekends.

YOUR ROLE:

Monitor compliance to meet or exceed site SOPs/cGMPs during production and packaging operations.
Perform required QA inspections; i.e Sample defect detection
Ability to participate in internal audits, as requested.
Provide primary daily support to the operations/packaging area, up to and including tasks such as packaging line clearance verification, material segregation/containment, low product fill response, rework reconciliations/accountabilities, and documentation real time review.
Primary QA event response personnel that will respond to exceptions within the operations/packaging areas, having functions of initial exception impact assessment, product containment, bracketing, initial scope identification, and direction of immediate actions to take prior to resuming processing.
Assist personnel in the generation of operations/packaging area related exceptions
Have the ability to support minor exceptions
Attend daily operations staff communication meetings
Team member of Facilities meetings regarding operations Preventive Maintenance/Calibration/Work Order status and scheduling
Team member during area shutdown or maintenance projects as needed. Assisting in punch list generation & verification, as well as, area inspections pre/post activity.
Perform weekly walkthroughs of the operations/packaging area and communicate any observations to associated area management.
Ability to support the QA label release functions on an as needed basis

YOUR BACKGROUND:

Education required/preferred:

Associates degree in Science/Business preferred

Bachelor’s degree in life sciences preferred

Your Experience:

Minimum 4 years experience in a pharmaceutical QA/Mfg environment

Preferred Skills/Qualifications/Competencies:

ASQ inspection certification preferred
Previous experience with statistical sampling plans (preferred)
Previous experience in investigation root cause analysis and/or writing (preferred)
Ability to work in fast paced environment
Ability to adjust work schedule to meet operations and customer demand
Must be able to wear appropriate personal protective equipment to insure safe execution of job responsibilities
Skilled competency with computers, MS Office software required. Experience with pharmaceutical CAPA systems (e.g., Trackwise, Metric Stream, etc.) preferred

WORKING CONDITIONS:

Pharmaceutical production and packaging areas. Personnel must have ability to stand on their feet for prolong period of time while performing operations support tasks, but can also experience a typical office environment throughout the work hours.

EQUAL EMPLOYMENT OPPORTUNITY

Guerbet is committed to a policy of Equal Employment Opportunity and will not discriminate against an applicant or employee based on race, color, religion, creed, national origin or ancestry, sex, sexual orientation, gender identity or expression, age, physical or mental disability, veteran or military status, genetic information, or any other legally recognized protected basis under federal, state, or local law. The information collected by this application is solely to determine suitability for employment, verify identify, and maintain employment statistics on applicants.

Applicants with disabilities may be entitled to reasonable accommodation under the Americans with Disabilities Act and certain state or local laws. A reasonable accommodation is a change in the way things are normally done which will ensure an equal employment opportunity without imposing undue hardship on Guerbet. Please inform the company’s personnel representative if you need assistance completing this application or to otherwise participate in the application process.

Guerbet provides accommodations to applicants and employees with disabilities. If you need an accommodation to apply for a position please send an email to careers@guerbet.com.

WHY GUERBET?

4 weeks of PTO
Exempt-employee benefits start on start date, non-exempt benefits start a month after hire
Competitive 4% 401K match + 2% profit sharing contribution
Tuition reimbursement program for ongoing education