CAPA Compliance Investigator
Company: Kelly Services
Location: Los Angeles
Posted on: April 9, 2021
Kelly Services-- has been providing outstanding employment
opportunities to the most talented individuals in the marketplace.
We are proud to offer a long-term temporary opportunity to work as
a CAPA Compliance Investigator at a prestigious Fortune 500--
company working in Los Angeles, CA--Important information:--This
position is recruited for by a remote Kelly office, not your local
Kelly branch. To be considered for this position, you must use the
"Submit Resume" button to submit your resumes. If you have
questions about the position, you may contact the recruiter for
this position () however your resume must be received via the
"Submit Resume" button included within.--Job Title: CAPA Compliance
Investigator--Pay: $40 per hour depending on experience --Position
Summary:The position will conduct root cause investigations, close
deviations, support assignment of proper corrective actions, and
facilitate implementation for Manufacturing under the direction of
Compliance Management.Perform calculation, data collection in
support of QC lab site, global CI initiatives, and management
reviews. Participate in the development and technical writing of
documentation for the validation of equipment and required to
support testing of the Los Angeles Manufacturing Facility. Lead
and/or drive completion of Lean or Six Sigma improvement projects
and responsible milestones, as assigned. --May function as a backup
Supervisor. Ensure that the daily operations of assigned functional
area are met through scheduling, troubleshooting and
- Support and/or lead continuous improvement projects such as
Yellow Belt, Green Belt, 5S, Kaizen, Just-do-it's, VIPs using
Lean/DMAIC concepts and philosophy.
- Assist Compliance Supervisor in leading daily operations to
ensure coordination and efficiency.
- Participate in the generation of test plans, protocols, and
reporting documentation for the validation of equipment supporting
testing of the LA Facility.
- Perform review of test data with application of GDP.
- Use Global LIMS or other computerized systems for entering,
approving, and trending test results.
- May be required to conduct investigations and/or audits into
- Actively contribute to a team setting at the Los Angeles
Manufacturing Facility and potentially with other work teams to
increase efficiency, solve problems, generate cost savings, improve
quality, and provide new product support, as needed.
- Provide training and work direction for assigned functional
- Investigate deviations and write exception documents as
required, utilizing problem-solving tools as needed.
- Maintain data integrity and ensure compliance with company SOPs
and specifications, FDA, GLP, QSR, and cGMP regulations.
- May be required to generate, execute, and/or summarize studies
and/or review/revise of SOPs. Complete and/or direct completion of
special project/protocol testing in a timely manner.
- Assist Compliance Supervisor in updating department metrics and
report shift activities, as assigned.
- Ensure personal training requirements are met and that training
records are current.
- May perform disposal of hazardous waste.
- Write and manage deviations (CAPA investigations, UIs, ICARs,
OOXs, containment and/or corrective actions) under the direction of
- Lead and/or facilitate problem solving events. Lead the
investigation closure of manufacturing compliance related
documents. Using quality and statistical tools to identify and
implement proper corrective and preventative actions to
- Represent the departments during the product release process,
compliance, and Continuous Improvement projects and audits.
- Participate in deviation related meetings and provide feedback,
leadership, and support to manufacturing supervisors, trainers and
manufacturing technicians on the status of compliance of the
- Conduct mediations to ensure timely release of product for
customers. Assist in meeting product release time goals.
- Emphasize training programs designed to enable staff to
consistently execute all manufacturing processes with strict
compliance to cGMPs and EHS regulations.
- Identify and implement process improvement and Value
Improvement Projects (VIP) to drive success in the areas of
compliance, throughput, workplace safety, cost effectiveness, and
product lead time.
- Participate in regulatory and non-regulatory
- Ability to handle multiple tasks concurrently and complete
tasks in a timely manner.
- Effective organizational skills and ability to plan and suggest
resolutions to technical problems.
- Demonstrated working knowledge of assays/equipment in
- Must be detail-oriented, conscientious, and responsible.
- Capable of applying some decisions-making to problem-solve
technical, compliance, or operational problems, as assigned.
- Effective interpersonal communication.-- Must have effective
verbal and written communication skills.
- Can demonstrate the ability to guide people, encourage
teamwork, and teach.
- Working knowledge of applicable CTP/SOPs, EHS requirements, and
application of cGMP/GDPs.
- Good project management skills a plus.
- Must be able to learn new computer systems and programs in a
- Demonstrate interpersonal skills with the ability to interface
and influence with personnel of all levels and participate
effectively and efficiently in a team environment.
- In-depth process knowledge of related manufacturing equipment
- Ability to analyze and interpret scientific and statistical
- Experienced understanding of cGMP and other regulatory
guidelines applicable to the medical/bio-tech industry.
- Lead investigation and provide comprehensive investigation
write up and/or presentations
- Working knowledge of Quality Systems
- Good computer skills and working experience with Microsoft
Office applications.--Education:Typically requires bachelor's
degree in chemistry, biological science, or other related technical
field.-- 2+ years of related experience.--Physical Demands &
- Must be able to lift, push, pull and carry up to 25 lbs and
push up to 50 lbs.
- In general, the position requires a combination of sedentary
work and walking around observing conditions in the facility.
- Must be able to work in controlled environments and cool/hot
storage conditions requiring special gowning. Will be required to
follow gowning requirements and wear protective clothing over the
head, face, hands, feet and body.
- No make-up, jewelry, contact lenses, nail polish or artificial
fingernails may be worn in the manufacturing environment.
- Will be working in a loud area that requires hearing protection
and other protective equipment to be worn.
- 20/20 near vision required (corrected vision is
- Will work in a cold, wet environment
- Will work around chemicals such as alcohol, acids, and
alkalines that requires protective equipment
- May be required to work or be assigned to a different shift as
- Must be able to work overtime as required.
- May be required to work in a confined area. Inside and Outdoor
- Perform removal of hazardous waste------We invite you to
bookmark our Web site and encourage you to review it regularly for
new opportunities worldwide: .Kelly Services-- is a U.S.-based
Fortune 500 company. With our global network of branch locations,
we are uniquely positioned to provide our customers with
international staffing support and our employees with diverse
assignments around the world.Kelly Services is an Equal Opportunity
Employer----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
Keywords: Kelly Services, Los Angeles , CAPA Compliance Investigator, Other , Los Angeles, California
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