QA Document Control Labeling Specialist
Company: American CyberSystems, Inc.
Location: Ayer
Posted on: May 8, 2022
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Job Description:
QA Document Control Labeling Specialist Location: Devens, MA
Duration: 12 Months PURPOSE AND SCOPE OF POSITION: The Quality
Assurance Label Control Specialist at the Devens Cell Therapy
manufacturing facility is responsible for supporting site Label
Control activities at Devens in accordance with policies,
standards, procedures and Global current Good Manufacturing
Practices (cGMPs). Functional responsibilities include performing
drug product label printing activities; ensuring accurate and
timely issuance of labels for manufacturing and packaging labeling
activities for Cell Therapy Development and Operations (CTDO). The
Quality Assurance Label Control organization is responsible for the
establishment, maintenance and continuous improvement of the
clinical and commercial label control process, procedures, and
responsibilities for achieving quality policies and objectives.
This organization supports the Devens facility to ensure patient
safety, regulatory requirements and improve its effectiveness and
efficiency on a continuous basis. REQUIRED COMPETENCIES: Knowledge,
Skills, and Abilities: * Knowledge and experience with GMP,
Quality, and compliance preferred. * Able to write and review
technical reports with clarity and brevity; provides guidance to
other team members in technical writing skills. * Requires moderate
direction to complete more complex tasks; completes routine tasks
with little or no supervision. * Must be organized and possess an
independent mindset. * Good understanding of electronic document
management and manufacturing execution systems. * Demonstrated
proficiency with PC-based office computers and standard Microsoft
Office applications. * Confident in making decisions for
non-routine issues. * Routinely recognizes and addresses quality
opportunities to improve overall process/project efficiencies. *
Proposes solutions for complex issues and works with management to
resolve. Follows established procedures and performs work as
assigned. * Builds relationships and effectively communicates
internally within the function and with internal and external
cross-functional teams. Interacts with internal and external
cross-functional teams. Represents department in internal and
external cross-functional teams. * Contributes to goals within the
work group. * Able to recognize conflict and notify management with
proposed recommendations for resolution. * Able to prepare written
communications and communicate problems to management with clarity
and accuracy. * Able to produce data reports with precision. * Able
to support internal and health authority inspections of facility
EDUCATION AND EXPERIENCE: B.S. Degree preferred, minimum 2 years
relevant work experience Equivalent combination of education and
experience acceptable DUTIES AND RESPONSIBILITIES: * Supports all
activities for the Quality Assurance Label Control group. *
Responsible for issuing clinical and commercial final product
labels for product batches during specified work hours, which may
include scheduled nights, weekends and holidays. * Responsible for
ensuring accurate printed information on labels in compliance with
health authority requirements. * Coordinates with production teams
to ensure timely issuance of labels. * Performs training of label
control and issuance requirements for internal personnel as needed.
* Ensures standard operating procedures (SOPs) related to job
responsibilities define the steps necessary to complete tasks, etc.
Writes, reviews and updates SOPs as required. * Carries out plans
and actions to support new drug product launches, new market and
other quality management activities as assigned. * Provides support
during internal and health authority inspections and audits of
facility. * Knowledge of quality processes, including label control
and issuance, change control, product complaints, deviations,
investigations and Corrective Action/Preventative Action (CAPA)
management. * Performs supplemental investigations/projects as
required by Management. * Maintains knowledge of cGMPs and
regulatory guidelines.
Keywords: American CyberSystems, Inc., Nashua , QA Document Control Labeling Specialist, Other , Ayer, New Hampshire
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