Sr. Specialist, Quality Assurance Compliance, Biologics, Tustin, CA
Company: Kelly Services
Posted on: April 9, 2021
Sr. Specialist, Quality Assurance Compliance, Biologics, Tustin,
CAPosition Type/Expected Hours of Work:This role is a full-time,
exempt position. Days and hours of work are Monday through Friday,
8:30 a.m. to 5 p.m.Summary:As an individual contributor, performs a
wide variety of activities to ensure compliance with applicable
quality and regulatory requirements by conducting internal and
external audits, data and documentation reviews and analysis.
Prepares audit reports regarding compliance findings and concerns
and provides recommendations for corrective actions. Coordinates
resolution of quality issues with suppliers and monitors quality
metrics. Writes and revises SOPs. This position focuses on
regulatory compliance, strict adherence to the company's quality
policy, in addition to improving and implementing cGMP
- Support the Director, Quality Assurance Compliance by
conducting internal audits of Operations and Quality Systems and
external audits of vendors. Follow up on internal and external
audit results to ensure appropriate responses during
- Develop solutions to complex issues and Quality initiatives
following cGMP regulations
- Perform tasks and work to achieve company goals and
organizational objectives.Essential Duties and
Responsibilities--include--but are not limited to the following:
- Follow company policies and procedures.
- Establish work priorities to meet targets and timelines.
- Perform independent internal and external audits for adherence
to cGMPs and other relevant Federal, foreign and corporate
regulations and policies.
- Follow up on audit response and corrective actions.
- Review data, records and documents to assess appropriateness of
investigation, root cause identification and corrective action
- Serve as the Quality Compliance representative on
- Identify, design, and implement process and system
- Evaluate regulatory requirement changes, impact to company's
operations and make recommendations to management.
- Support client audit and regulatory inspection (FDA and
- Serve as a technical subject matter expert (SME) in support of
- Mentor junior personnel serving as a subject matter expert
(SME) on Quality systems, processes and issues.
- Notify Management of potential quality or regulatory issues
that may affect product quality or regulatory compliance.
- May conduct investigations related to non-compliance
- Review and approve quality management records.
- Participate in discrepancy investigations. Ensure discrepancies
are thoroughly identified, defined and properly assessed.
- Participate in company audit readiness activities.
- Interact with interdepartmental contacts on discrepancy
assessment, resolution, and quality approval.
- Provide guidance to internal and external customers on best
practices for maintaining a quality program.
- Ensure that the proper policies and procedures are in
- Identify, design, and implement process improvements.
- Provide input into the design and presentation of departmental
- B.A. or B.S. degree (preferably in Life Science) and at least
5-6 years of experience in the pharmaceutical, biopharmaceutical or
related industry, or an equivalent combination of education and
- Internal and External Audit experience and/or certification is
- Sound knowledge of cGMPs or equivalent regulations
- Ability to interpret and relate Quality standards for
implementation and review
- Ability to make sound decisions about scheduling, allocation of
resources, and managing priorities
- Ability to communicate clearly and professionally both in
writing and verbally
- Skillful in problem solving and analytical thinking.
- Flexibility in work hours to meet business objectivesFor
Immediate Consideration, Apply Today! Questions? Call Grace at
714.253.7656, Email at email@example.com, or--schedule a
time to connect directly follow the link:--Why Kelly--?Kelly
Science & Clinical is your connection to premier scientific and
clinical companies looking to hire talented people just like you.
Every day, we match science professionals with dream jobs that fit
their skills and interests-it's the way we think job searching
should be. Nearly 100 percent of our science recruiters have a
professional background/education in science, so we know a thing or
two about the science market and how to get you noticed.About
Kelly--At Kelly, we're always thinking about what's next and
advising job seekers on new ways of working to reach their full
potential. In fact, we're a leading advocate for
temporary/nontraditional workstyles, because we believe they allow
flexibility and tremendous growth opportunities that enable a
better way to work and live. Connecting great people with great
companies is what we do best, and our employment opportunities span
a wide variety of workstyles, skill levels, and industries around
the world. Kelly is an equal opportunity employer committed to
employing a diverse workforce, including, but not limited to,
minorities, females, individuals with disabilities, protected
veterans, sexual orientation, gender identity. Equal Employment
Opportunity is The Law.]]
Keywords: Kelly Services, Tustin , Sr. Specialist, Quality Assurance Compliance, Biologics, Tustin, CA, Other , Tustin, California
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