QA Inspector AHFM
Thousand Oaks, CA
Req ID 51090BR
Business Title
QA Inspector - AHFM
Business
Global Quality
Sub-Business
BioScience Support
Country
US
State/Province
California
Location of Position
Thousand Oaks, CA
Shift_
1st
Job Description
Summary:
Responsible
for the inspection activities associated with the Formulation/Finishing
manufacturing processes. Including aseptic filling, overcapping, label
stores and packaging areas while strictly adhering to cGMP,
environmental health and safety guidelines and any other related
regulations that may apply. Individual is expected to fully participate
in both departmental projects and any quality working teams that may
be applicable.
Essential Duties or Responsibilities:
Responsible
for the inspection activities associated with the Formulation/Finishing
manufacturing processes. Including aseptic filling, overcapping, label
stores and packaging areas while strictly adhering to cGMP,
environmental health and safety guidelines and any other related
regulations that may apply. Individual is expected to fully participate
in both departmental projects and any quality working teams that may
be applicable.
Responsibilities include, but are not limited to:
•Oversight/Monitoring of aseptic technique during filling and capping operations. •Issuance/Reconcilliation of labeling for packaging operations. •Managing of labeling material in warehouse. •Perform visual inspection and AQL sampling of final container vials. •Perform AQL sampling of final packaged product. •Perform final drug product release into warehouse. •Operate Forklift. •Perform tagging and untagging activities for quarantined material. •Perform JDE inventory transactions. •Participate on Continuous Improvement Teams. •May perform other duties as assigned.
Job Requirements
Qualifications:
•Knowledge of good aseptic techniques/practices. •Knowledge of cGMP. •Knowledge of Code of Federal Regulations 21 CFR - Parts 210 & 211. •Must be able to read, write and converse in English. •Must be able to read and follow detailed written instructions and have good verbal/written communication skills. •Good interpersonal skills and be able to work effectively and efficiently in a team environment. •Must
be able to navigate, conduct searches, and fill on line Forms on
Personal Computer for the purposes of training, performance management,
and self service applications. •Must have the ability to navigate electronic mail systems and intranet for communication purposes. •Must have good interpersonal skills and be able to work effectively and efficiently in a team environment. •Must
have the following personal attributes: integrity and trust, work
ethic, sound judgment, intellectual honesty, pragmatism, courage and
conviction. •Must have passion to innovate and drive for solutions. •Must display personal accountability for results and integrity. •Must display eagerness to learn and continuously improve. •Must have uncompromising dedication to quality. •Must have relentless focus on rapid and disciplined action. •Must have respect for individuals and the diverse contributions of all. Education and/or Experience:
•Requres
a BA/BS with 0-2 years related experience or AA/AS degree with 1- 3
year(s) related experience or a High School Diploma with 2 - 4 years
related experience. Experience in biotech industry within
Formulation/Packaging areas desirable. Working Environment:
•Must be able to support a 4-10hr work week. Wednesday - Saturday •Must
be able to work in controlled clean room environment 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, jewely, nail polish or artificial fingernails may be worn in
the work environments. •Must be able to work more than 8 hours a day or 40 hours a workweek as required. •Overtime may required at times. (Including weekends, holidays if required) •Will have interaction with other people. •May be required to work or be assigned to a different shift as needed. •Will have interaction with other people. •Pace may be fast and job completion demands may be high. •Work Hours:Tuesday - Saturday 6:00am - 2:30 pm.
Doing Work that Matters
Baxter provides its employees with comprehensive compensation and benefits. To view additional opportunities at Baxter and to learn more about the company, please visit our Web site at company website. EOE M/F/D/V.
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