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QC Coordinator
1 week ago
Actalent Covington, United States Full timeTO APPLY EMAIL YOUR RESUME AT MJESSIE @ACTALENTSERVICES.COM · Pay: $28/ hr · Location: Covington, Ohio · Description: · The QC Lab Coordinator is responsible for ensuring that environmental swabbing, swab testing and chemistry testing is performed during the shift as required. ...
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QC Coordinator
2 days ago
Actalent Covington, United States Full timeDescription: · The QC Lab Coordinator is responsible for ensuring that environmental swabbing, swab testing and chemistry testing is performed during the shift as required. · Perform routine environmental monitoring swabbing in the facility · Perform investigative environmental ...
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Medical Research Technician
1 week ago
Tulane University Covington, United States StaffSummary · The Division of Microbiology, Tulane National Primate Research Center has an exciting opportunity for a Medical Research Technician. Under the direction and supervision of the Principal Investigator and the Laboratory Supervisor, this individual will work in active res ...
Supervisor Microbiology - Covington, United States - Taleo BE
Description
By clicking the "Apply" button, I understand that my employment application process with Takeda will commence and thatthe information I provide in my application will be processed in line with
Takeda's
Privacy Notice
and
Terms of Use .
I further attest that all information I submit in my employment application
is
true to the best of my knowledge.
Job Description
As the Supervisor Microbiology, you will supervise a team performing multiple biological, chemical, or physical analyses on pharmaceutical products (biologics and drugs) through all stages of the manufacturing process from incoming raw materials to finished goods and may include environmental monitoring programs.
You may be applicable to QC Analytical or Microbiological testing, Compliance, QCMIS, or Laboratory Operations. You will be responsible for results regarding product quality and conformance to regulations and quality policies.How you will contribute
Plan and schedule the work of QA analysts, QA technicians and inspectors.
Ensure that all document control activities, inspection, and test procedures are completed and documented.
Review all quality assessment results and determine whether to accept or reject manufactured products during the inspection process.
Coordinate the release of licensed products, intermediate and clinical/IND lots, and Packaging, according to schedule.
Track performance indicators such as average number of defects per million units inspected as a process average for all products and document control and retention schedule adherence.
Work with Production Supervision, Quality, and Engineering to ensure adequacy and appropriateness of inspection parameters, product specifications, test methods, and other controlled documentation.
Evaluate new raw materials to develop first of code criteria for raw material testing.Prepare daily reports and monthly summary on department specific performance indicators.
Maintain inspection documentation procedures, QA inspection instructions and department policy procedures. Ensure product compliance regulations are followed.
Oversee the team and direct management of individuals, including goal setting, performance feedback, skills development and mentoring.
Navigate, answer alerts and review Batch Records in EBM.
Provide necessary floor support to the manufacturing teams and help in resolving compliance concerns.
Responsible for change control activities/documentation. Required to perform review of submission documents applicable to the product of the department.
Coordinate quarterly review meetings of quality data and trends to upper management.
Coordinate customer complaint response and tracking.
What you bring to Takeda
Typically requires a bachelor's degree in science, engineering or other related technical field and 5+ years of related experience.
Some leadership experience.
Working knowledge of statistics and production processes.
Must have AS400 or PC knowledge.
Identify when proper practices/ procedures are not performed.
Follow SOPs and identify processes and results.
Complete changes and corrections.
Driver of task proficient.
Escalate accordingly.
Ensure communication of issues.
Ensure communication between personnel, groups, and between departments.
Coordinate activities, schedules staff.
Important Considerations
In general, you will have a combination of sedentary work, standing work, and walking around observing conditions in the facility.
May work or be assigned to a different shift to meet needs. Must be willing to work off shifts hours.
Will work supplemental hours to complete work commitments.
May work in a confined area.
Inside working conditions.
Some clean room and cool/hot storage conditions.
You may be allocated in QC Analytical, Microbiology, Compliance, QCMIS, and Laboratory Operations with general job requirements summarized below:
Wet/dry chemistry or biochemistry test methods, compendial raw material testing, maintenance of associated assay equipment, and reconcilitation of test results.
Environment monitoring, critical utility sampling, endotoxin testing, bioburden for raw materials and in process, process samples, microbial identification and final product sterility testing.
Manage and investigation of non-comformance events (OOL, OOS). Develop the site Contamination Control Master Plan (CCMP).Development, validation, and optimization of departmental assays.
Support laboratory operations through sample control, equipment metrology, data reconciliation/ archiving, or computerized system programming and support.
More about us:
At Takeda, we are transforming patient care through the development of novel specialty pharmaceuticals and best in class patient support programs.
Certified as a Global Top Employer, Takeda offers stimulating careers, encourages innovation, and strives for excellence in everything we do.
We foster an inclusive, collaborative workplace, in which our teams are united by an unwavering commitment to deliver Better Health and a Brighter Future to people around the world.
This posting excludes Colorado applicants.Takeda Compensation and Benefits Summary
We understand compensation is
an important factor
as you consider the next step in your career. We are committed to
equitable
pay for all employees, and we strive to be more transparent with our pay practices.
For Location:
USA - GA - Social Circle - Hwy 278
U
S Base Salary Range:
$84, $132,000.00
The estimated salary range reflects
an anticipated
range for this position. The actual base salary offered may depend on a variety of factors, including the qualifications of the individual applicant for the position, years of relevant experience, specific and unique skills, level of education
attained
, certifications or other professional licenses held, and the location in which the applicant lives and/or from which they will be performing the job.
The actual base salary offered will be
in accordance with
state or local minimum wage requirements for the job location.
U.S. based
e
mployee
s
may be eligible for
s
hort
t
erm and/
or
l
ong-
t
erm
incentive
s
.
U.S.
based employees
may be
eligible to
participate
in medical, dental, vision insurance, a 401(k) plan and company match, short-term and long-term disability coverage, basic life insurance, a tuition reimbursement program, paid volunteer time off, company holidays, and
well-being
benefits, among others. U.S.
based employees are also eligible to receive, per calendar year, up to
80 hours
of sick time, and new hires are eligible to
accrue
up to
120 hours of paid vacation.
EEO Statement
Takeda is proud in its commitment to creating a diverse workforce and providing equal employment opportunities to all employees and applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, gender expression, parental status, national origin, age, disability, citizenship status, genetic information or characteristics, marital status, status as a Vietnam era veteran, special disabled veteran, or other protected veteran in accordance with applicable federal, state and local laws, and any other characteristic protected by law.
LocationsUSA - GA - Social Circle - Hwy 278
Worker Type
Employee
Worker Sub-Type
Regular
Time Type
Full time
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