ASQ 0502 JobSeekers

Job Description:

Clinical Quality Assurance (CQA) Manager

·    Assist management in implementing CQA audit programs and audit plans in
accordance to DVC CQA SOPs and/or based on the type and complexity of
the trial, the number of subjects in the trial and the level of risks to
the subjects.
·    Plan and conduct audits, including generating documentation to support
audits, according to DVC standard operating procedures (SOPs).  Perform
internal and external GCP audits to ensure overall trial conduct is in
compliance with the clinical protocol, SOPs, study specific procedures
(SSPs) and applicable regulations/guidelines.
·    Review documentation supporting clinical trial conduct to ensure
compliance to applicable regulations, guidelines, protocol, SOPs and
SSPs, as applicable.
·    Maintain working knowledge of DVC procedures/guidelines as well as FDA
and ICH regulations and guidelines.
·    Accurate and detail orientated.  Ensure efficient, high quality
deliverables.
·    Maintain CQA audit files.
·    Create and revise CQA SOPs, template forms and reports, as necessary.
·    Maintain GCP references in the department and for the company.
·    Represent CQA and participate in multiple project team meetings and
provide counsel, as appropriate, on regulatory/compliance issues.
·    Provide direction, coordination and monitoring for audit activities.
·    Ability to handle and follow up on multiple tasks and projects.
·    Ability to perform work on projects of moderate complexity with minimal
supervision
·    Participate in and conduct training in QA related topics within DVC and
to external groups, as assigned.

Education/Experience (required for the position):

·    Bachelor’s degree (BA or BS); degree in a science field preferred, or
equivalent years of experience.
·    Minimum of 4 years experience in the biologics, pharmaceutical and/or
medical device industry as a GCP auditor or equivalent in a clinical
quality assurance decision-making capacity.  CRA experience can be
included within the years of experience, although a minimum of 2 years
of auditing experience is required.
·    Must have working knowledge of local, state, and federal regulations
pertaining to Good Clinical Practices, in addition to ICH guidelines.
Must have working knowledge of drug, biologics/device clinical trial
development processes and clinical monitoring practices.
Computer literacy in MS Office product suite.
·    Excellent verbal and written communication skills
·    Ability to handle and follow up on more than one task or project.
·    Ability to perform work with minor supervision

Company info:

DynPort Vaccine Company LLC, a CSC company, manages product development
programs for U.S. government agencies, and provides consulting services to
biotechnology and pharmaceutical companies.
DVC has been named to The Scientist Best Places to Work in Industry List
for the third consecutive year. Learn more about the ranking, or check out
our job openings including contracts, regulatory, manufacturing and new
business positions.
Whether you’re single, married with children or approaching retirement, we
offer a complete compensation package with benefit options.  Employees are
eligible for benefits on the first day of employment. CSC offers generous
sick, vacation and holiday leave.  Each DVC employee receives nine paid
holidays per year and may accrue a maximum of ten paid sick leave per
year.
CSC also offers the CSC Matched Asset Plan (CSC’s 401(k) plan).  Along with
your employment at DVC, even more company-provided benefits are at your
disposal.
Long-Term Care Program
PC Loan Program
Employee Referral Awards
Life Management – Employee Assistance Plan
Employee Discount program – special offers and discounts
CSC Credit Union
DVC values and supports further education through several learning
opportunities.
Tuition reimbursement
Extensive online course offerings and books
Instructor-led courses on site
On-the-job training

Please let me know if you have any questions regarding the posting.  My
contact information is listed below.

Thank you,

Linda Dunsmoor, CMQ/OE
Director of Quality Systems, DynPort Vaccine Company LLC
CSC