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Quality Assurance/GMP Compliance Specialist:
(Part Time leading to Full Time Position)
SL
Pharma Labs Inc.,
a well established and fast-growing
Pharmaceutical R&D contract lab located near
Wilmington, DE, with easy access to I-95, is
hiring for multiple positions. Most positions
are for Full Time however some are Part-Time
leading to Full Time. We offer a fast paced,
challenging work environment and a flexible
schedule. We have an immediate Part Time
opening for a
Quality Assurance/GMP Compliance Specialist.
Quality
Assurance/GMP Compliance Specialist:
The position involves hands-on responsibility
for all
QA/ GMP Compliance activities associated with
the development and validation of chemical and
microbiological test methods used for
pharmaceutical development studies, release
testing and stability studies. The position
also provides quality oversight for the
manufacture of clinical supplies.
Candidates must have a BS/MS in Analytical
Chemistry (preferred) or related scientific
discipline with 3 to 5 years proven hands-on
Quality Assurance experience in the
pharmaceutical industry with experience in a
laboratory environment. The successful
candidate must have in-depth working knowledge
of regulatory compliance requirements (GLP/GMP),
must
be a self-starter with effective communication
and leadership skills, and must have the ability
to work independently to achieve results.
The
Quality Assurance/GMP Compliance Specialist
will assume responsibility for existing QA/ GMP
Compliance activities with responsibility to
develop and improve the Quality Systems that
impact cGMP compliance within the Company.
Responsibilities include review of technical
data in lab notebooks and logs, review and
approve SOP’s and technical reports, maintain
the change control system, and participate in
the investigation of non-conformances. Other
duties include conducting GMP audits, periodic
Compliance Meetings, training/re-training staff,
coordinating equipment calibration and assuring
the completeness of GMP documentation. The
Quality Assurance/GMP Compliance Specialist
will act as the key person for dealing with all
client’s audits and FDA inspections and
responding to their findings
SL Pharma Labs
does not provide compensation for candidate's
travel or relocation expenses. Candidates who
are US Citizens or legal residents of the USA
residing within commuting distance of
Wilmington, Delaware, will be preferred.
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