Quality Specialist
Company: Avantor
Location: Morrisville
Posted on: January 24, 2023
Job Description:
Job SummaryUnder moderate supervision, responsible for technical
quality tasks, including inspecting and processing raw materials
and reviewing and releasing finished products. Perform Batch Record
Review and manufactured product release processing. Observe cGMP
good documentation practices.Available Shift? Monday - Friday,
7:30am to 4:00pm
Why Avantor?
- Full-Time Health Benefits on Your First Day
- Sign-On Bonus
- Quarterly Incentive Bonuses paid
- Competitive Time off Package (PTO and Holidays)
- Employee Stock Options
- Retirement Plan Options with company match
- Direct HireWhat does the position do?
- Follows company policies, procedures, work instructions, and
training requirements focusing on customer service, production, and
quality.
- Keeps customer interests and regulatory requirements in mind,
ensures customer needs are met by reviewing order requirements,
customer documentation requirements, proper filling and assembly
requirements, and, where needed, ensures other technicians
understand and follow documented VWR Solon procedures and GMP
requirements.
- Ensures customer requirements are met.
- Verifies adherence to policies, procedures, and work
instructions.
- Ensures documentation and physical product segregation and
containment of non-conforming material identified during the
production process.
- Reviews production documentation for accuracy, completeness,
and GDP compliance.
- Assists in correcting order issues and ensures actions that are
taken are appropriate.
- Communicates issues / concerns to area owner and direct
manager.
- Ensures that the area is in a state of "audit readiness" at all
times.
- Performs inspection tasks by following established work
instructions and procedures, by using required tools and methods
and, when applicable, equipment, to determine acceptability of
product, components, and documentation.
- Performs pre-fill, in-process, and final inspections with the
aid of documented work instructions and inspection information as
the need arises.
- Stops production when a non-conformance (NCM) is observed and
follows appropriate NCM procedures.
- Documents non-conformances following applicable VWR Solon
procedures and work instructions.
- Documents and trends any quality production issues discovered
during the course of inspection duties.
- Ensures cleanliness of work areas during the inspection
processes.
- Applies problem solving tools such as 5M+E, 5 Why's, or other
root cause analysis tools / methods to identify and permanently
resolve issues.
- Adheres to VWR Solon's QMS and VWR Policies, where
applicable.
- Walks the floor to observe, train, and facilitate / support
change.What do you need to have?
- High School completion or equivalent (GED) and a minimum of 3
years related experience and/or training in a regulated industry is
required; OR
- Bachelor's degree is required
- Experience in a Quality Assurance role within the medical
device, biotech, or pharmaceutical industry is preferredWhat would
be nice to have?
- Must be able to balance multiple tasks and prioritize
efficiently
- Knowledge of ISO 9001, ISO 13485, 21 CFR 820, 21 CFR 11, ISO
17025, or EXCiPACT standard
- Demonstrated experience or knowledge in conducting root cause
analysis as it relates to nonconforming material
investigations
- Knowledge and experience using Microsoft Outlook, Word, Excel,
and Access, or equivalent software packages
- Good interpersonal skillsWhat's the environment like?
- Works on the production floor with adequate lighting and
ventilation with occasional elevated noise levels and a varying
range of temperatures.
- Work assignments are diversified.
- Examples of past precedent are used to resolve work problems.
New alternatives may be developed to resolve problems.
- A frequent volume of work and deadlines impose strain on
routine basis.
- Minimal physical effort is required; however, the position does
require frequent walking, standing, bending, reaching, lifting or
possibly carrying objects weighing up to 50 lbs.
- While performing the duties of this Job, the employee is
occasionally exposed to fumes or airborne particles and toxic or
caustic chemicals.DISCLAIMER:
The above statements are intended to describe the general nature
and level of work being performed by employees assigned to this
classification. They are not intended to be construed as an
exhaustive list of all responsibilities, duties and skills required
of employees assigned to this position.
Avantor is proud to be an equal opportunity employer.EEO
Statement:We are an Equal Employment/Affirmative Action employer.
We do not discriminate in hiring on the basis of sex, gender
identity, sexual orientation, race, color, religious creed,
national origin, physical or mental disability, protected Veteran
status, or any other characteristic protected by federal,
state/province, or local law. If you need a reasonable
accommodation for any part of the employment process, please
contact us by email at recruiting@avantorsciences.com and let us
know the nature of your request and your contact information.
Requests for accommodation will be considered on a case-by-case
basis. Please note that only inquiries concerning a request for
reasonable accommodation will be responded to from this email
address.For more information about equal employment opportunity
protections, please view the Equal Employment Opportunity is THE
LAW Poster, EEO is the Law Poster Supplement, and Pay Transparency
Non-Discrimination Provision using the links below.EEO is the
LawOFCCP EEO SupplementPAY TRANSPARENCY NONDISCRIMINATION
PROVISION3rd Party Non-Solicitation Policy:By submitting candidates
without having been formally assigned on and contracted for a
specific job requisition by Avantor, or by failing to comply with
the Avantor recruitment process, you forfeit any fee on the
submitted candidates, regardless of your usual terms and
conditions. Avantor works with a preferred supplier list and will
take the initiative to engage with recruitment agencies based on
its needs and will not be accepting any form of solicitation.
Keywords: Avantor, Cary , Quality Specialist, Other , Morrisville, North Carolina
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