Manager, Quality Assurance (Hybrid)
Company: Sharp Services, LLC
Location: Bethlehem
Posted on: August 8, 2022
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Job Description:
Summary Responsible for providing oversight of Quality Assurance
Specialists and batch record reviewers to assure compliance with
internal procedures and regulatory requirements.Provides Quality
Assurance supervisory oversight of assigned QA functions and areas
of manufacturing to ensure drug products are processed in
accordance with cGMPs and other applicable regulatory requirements
for drug products and medical devices. Responsible to assess,
investigate and effectively resolve processing issues in
conjunction with subject matter experts, and in accordance with
standard operating procedures.Responsible for contact with QA
representative's internal and external customers regarding quality
issues related to manufacturing/packaging and resolution of
issues.Essential Duties and Responsibilities Provide leadership and
direction for the QA Specialists and Batch Record ReviewersOversee
the key quality processes that impact/relate to product compliance
including batch record review and product release, compliance in
movement and storage of materials, Investigations, and CAPAs as
related to product complianceResponsible for assuring all customer
complaints, and product related Investigations/CARs are completed
in a timely mannerProvide oversight to the master batch record
issuance and batch release processes for Manufacturing and
PackagingTroubleshoot and direct the resolution of Quality issues
related to Packaging and Manufacturing by fostering effective
interdepartmental and cross-functional partnershipsEnsures products
(including services) are developed, manufactured, tested and
delivered according to established procedures that will assure that
they meet all quality requirements.Lead process improvement
initiatives related to Quality Assurance.Provide input to the
development of personal performance goals and departmental
objectivesCollaborate with Management to establish and meet targets
and timelines for the Quality DepartmentApply advanced theory,
technical principles, and expert judgment to address a broad range
of issues affecting product complianceServe as a technical subject
matter expert (SME) in support of department functionsManage
competing priorities and provide adequate support to QA staff as
requiredQualificationsTo perform this job successfully, an
individual must be able to perform each essential duty
satisfactorily. The requirements listed below are representative of
the knowledge, skill, and/or ability required. Bachelor's Degree in
a science or Technical fieldA minimum of 5 years' experience in a
regulated pharmaceutical or biopharmaceutical industryLeadership
experience in a QA, laboratory or production environment required,
including a demonstrated ability to identify problems, and initiate
successful corrective actions.Quality Assurance experience in an
operational or development setting with demonstrated knowledge of
techniques for assessing the quality of processes and the ability
to guide others in these activities.Advanced knowledge of GMPs, ISO
and other applicable regulatory requirements for pharmaceuticals
and medical devices and the ability to communicate this knowledge
to the entire organization professionally and succinctlySuperior
verbal and written communication skillsExperience with Microsoft
Office applications and ERP systemsHas adequate emotional
intelligence to handle a variety of situations professionally and
in accordance with regulatory compliance
Keywords: Sharp Services, LLC, Atlanta , Manager, Quality Assurance (Hybrid), Executive , Bethlehem, Georgia
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