Operational Quality Specialist
Company: GlaxoSmithKline
Location: Rockville
Posted on: May 16, 2022
Job Description:
Site Name: USA - Maryland - RockvillePosted Date: Apr 4 2022GSK
is currently looking for an Operational Quality Specialist to join
our team in Rockville, MD. The purpose of this role is to be the
first line of contact for operational quality advice and support
for Production and other site operational areas. - Drive for early
detection and help prevent potential quality issues. Review of
Batch Records for product that is manufactured in compliance with
regulatory agencies' requirements and company standardsKey
Responsibilities:
- Provides a Quality Oversight for the production areas including
Manufacturing, Warehouse, Laboratories, Facilities and Engineering.
- Perform rapid response, walk throughs, process assessments, and
change over walk-throughs
- Review GMP related documentation such as SOPs, MC,
Deviation/CAPAs, executed solution batch records and executed BDS
process batch records Master Batch Records, Glass Wash and
Autoclave records, cleaning logs, temperature charts, equipment
alarms and Technical Reports. Approves any changes associated with
these documents.
- Review EM and water data for facility and EM for bulk
fills
- Review executed protocols and summary reports for GMP
laboratory equipment, manufacturing equipment, facility utilities,
process controllers, IT systems and process validation
- Support/Perform L1 and L2 audits and Inspection Readiness
efforts making sure that area logbook and documentation is accurate
and reviewed in a timely manner
- Review Validations documents.
- Work across multiple value streams to drive continuous
improvement and promote quality culture. Utilizes and continuously
improves the GPS standards (i.e. 5s, standard work, problem
solving, Gemba, process confirmations, and performance management)
towards the goal of Zero Accidents, Zero Defects, and Zero
Waste
- Work closely with cross site teams to drive performance of
product disposition.
- Performs other functions as necessary or as assigned.Why
you?Basic Qualifications:We are looking for professionals with
these required skills to achieve our goals:
- Associates degree in Technical/Scientific disciplinePreferred
Qualifications:If you have the following characteristics, it would
be a plus:
- Bachelor's degree preferred
- 3+ years' experience in Manufacturing, Quality, QC environment
preferred. - -
- Knowledge of cGMP's/FDA and other Regulatory requirements such
as ICH Guidelines 8, 9, 10, 11. -
- Demonstrate initiative and analytical problem-solving skills -
ability to use and interpret data to drive decision making at both
tactical and strategic level. -
- Ability to work well under high pressure and deadlines -
- Must be flexible, adaptable, and a strong team player and a
leader that fosters teamwork and promotes GSK Values, Behaviours
and Strategies. -
- Excellent verbal and written communication skills.
- Conflict resolution and interaction management skills.
- Knowledge and application of the principles of Quality
Management Systems (QMS)Why GSK?At GSK, we have already delivered
unprecedented change over the past four years, improving R&D,
becoming a leader in Consumer Healthcare, strengthening our
leadership, and transforming our commercial execution. Now, we're
making the most significant changes we've made to our business in
over 20 years. We're on track to separate and create two new
companies in 2022: New GSK with a leading portfolio of vaccines and
specialty medicines as well as R&D based on immune system and
genetics science; and a new world-leading consumer healthcare
company of loved and trusted brands.With new ambition comes new
purpose. For New GSK, this is to unite science, talent, and
technology to get ahead of disease together - all with the clear
ambition of delivering human health impact; stronger and more
sustainable shareholder returns; and as a new GSK where outstanding
people thrive.Getting ahead means preventing disease as well as
treating it. How we do all this is through our people and our
culture. A culture that is -ambitious for patients -- so we deliver
what matters better and faster; -accountable for impact -- with
clear ownership of goals and support to succeed; and where we do
the right thing. So, if you're ready to improve the lives of
billions, join us at this exciting moment in our journey. Join our
challenge to get Ahead Together.*LI-GSKIf you require an
accommodation or other assistance to apply for a job at GSK, please
contact the GSK Service Centre at 1-877-694-7547 (US Toll Free) or
+1 801 567 5155 (outside US).GSK is an Equal Opportunity Employer
and, in the US, we adhere to Affirmative Action principles. This
ensures that all qualified applicants will receive equal
consideration for employment without regard to race, color,
national origin, religion, sex, pregnancy, marital status, sexual
orientation, gender identity/expression, age, disability, genetic
information, military service, covered/protected veteran status or
any other federal, state or local protected class.At GSK, the
health and safety of our employees are of paramount importance. As
a science-led healthcare company on a mission to get ahead of
disease together, we believe that supporting vaccination against
COVID-19 is the single best thing we can do in the US to ensure the
health and safety of our employees, complementary workers,
workplaces, customers, consumers, communities, and the patients we
serve. -GSK has made the decision to require all US employees to be
fully vaccinated against COVID-19, where allowed by state or local
law and where vaccine supply is readily available. The only
exceptions to this requirement are employees who are approved for
an accommodation for religious, medical or disability-related
reasons.Important notice to Employment businesses/ AgenciesGSK does
not accept referrals from employment businesses and/or employment
agencies in respect of the vacancies posted on this site. All
employment businesses/agencies are required to contact GSK's
commercial and general procurement/human resources department to
obtain prior written authorization before referring any candidates
to GSK. The obtaining of prior written authorization is a condition
precedent to any agreement (verbal or written) between the
employment business/ agency and GSK. In the absence of such written
authorization being obtained any actions undertaken by the
employment business/agency shall be deemed to have been performed
without the consent or contractual agreement of GSK. GSK shall
therefore not be liable for any fees arising from such actions or
any fees arising from any referrals by employment
businesses/agencies in respect of the vacancies posted on this
site.Please note that if you are a US Licensed Healthcare
Professional or Healthcare Professional as defined by the laws of
the state issuing your license, GSK may be required to capture and
report expenses GSK incurs, on your behalf, in the event you are
afforded an interview for employment. This capture of applicable
transfers of value is necessary to ensure GSK's compliance to all
federal and state US Transparency requirements. For more
information, please visit GSK's Transparency Reporting site.
Keywords: GlaxoSmithKline, Rockville , Operational Quality Specialist, Other , Rockville, Maryland
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