QC Raw Materials Manager
Company: GlaxoSmithKline
Location: Rockville
Posted on: May 15, 2022
Job Description:
Standort: USA - Maryland - RockvilleDatum: May 11 2022GSK
currently has an opening for a QC Raw Materials Manager in
Rockville, MD. The QC Raw Materials Manager is responsible for
planning and prioritizing resource allocation in a Rockville
Biopharma Quality Control laboratory to meet testing and release
requirements of raw materials and oversee the operation of QC
analysts. This role will be responsible for training, assisting in
transferring assays from the development group, qualifying and
validating new assays and implementing assays to be used for
quality control purposes to support manufacturing and marketing of
the product. The individual must have a thorough understanding of
cGMP regulations and compendia requirements and demonstrate the
ability to handle multiple priorities and interface with individual
from various departments.Key Responsibilities:
- Assures the laboratory programs/procedures are compliant with
all regulations (domestic and international), cGMP's, cGLP's, and
corporate requirements.
- Assures all areas of responsibility are operated according to
all safety regulations, procedures and expectations. - - - -
- Assures all laboratory data are generated and approved under
the current regulatory, GMP, and corporate guidelines. -
- Reviews, evaluates, and manages initiatives to improve Quality
Operations overall laboratory operational efficiency and GMP
performance. -Encourages excellence and drives continuous
improvement. - -
- Responsible for the management and final approval of
deviations, lab investigations, change controls, protocols. -
-
- Writes, updates, reviews and approves SOPs, Specifications,
method protocols/reports. Manages analytical technical transfers,
method validation, timelines and resourcing.
- Establishes laboratory team objectives, testing priorities, and
coordinates laboratory resources to align with objectives.
Responsible for the control, testing and ultimate disposition of
raw materials.
- Assures laboratory personnel are qualified through proper
training on appropriate departmental and site SOPs, training
modules, GMPs, regulations, etc.
- Participates in regulatory audits, agency inspections and the
site internal auditing program. - -
- Recruits, interviews, and hires laboratory personnel.
- Conducts performance reviews, implements Employee Development
Plans, and career pathing objectives with direct reports. -
Provides developmental opportunities for laboratory personnel
through training and project assignments. -The role requires office
work, computer work, group meetings, laboratory work and thus
requires sitting, standing, and walking. - It may involve working
with analytical instruments and thus may involve exposure to
chemical reagents that may be hazardous (corrosive, toxic,
flammable, etc.)The role may involve occasionally working outside
of 0800 - 1700 hours for on-call response to chambers or ADHOC Raw
Materials testing.Why you?Basic Qualifications:We are looking for
professionals with these required skills to achieve our goals:
- BS in Science field
- 7+ years' experience in Quality Control in pharmaceutical
biopharmaceutical industry
- 2+ years of supervisory experiencePreferred Qualifications:If
you have the following characteristics, it would be a plus:
- Demonstrated supervisory and leadership skills.
- Able to seek additional tasks or non-routine functions and
accomplish them with minimal supervision.
- Have knowledge of USP, EP, JP, ACC, BP, and ChP compendia
methods performed in a cGMP environment.
- Strong interpersonal and leadership skills. Solid team player
able to function within team-based organisation.
- Strong verbal and written communication skills.
- Able to interact with peers, subordinate and senior personnel
in multidisciplinary environment including procurement,
engineering, facility operations, validation, production and
QA.
- Able to prioritise and decide appropriate course of actions. -
Effective at implementing decision.
- Enthusiasm to identify and evaluate new assays and modern
technology in improving proficiency in laboratory operations.
- Have a continuous improvement mindset and drive performance and
change.
- Fully versed in GMP's, NIH, ICH Guidelines, FDA and other
regulatory agency requirements for qualification/validation and
testing of raw materials.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-GSK#globalsupplychain If 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 , QC Raw Materials Manager, Executive , Rockville, Maryland
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