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25 days old

2nd Shift QA/QC Technician

Kelly Services
Myerstown, PA 17067
**2nd Shift QA/QC Technician**



Myerstown, PA



Contract-to-Hire Opportunity



Shift: 3PM-11:30PM





**Responsibilities:**




+ Review non-conformance of production operations and equipment/materials with supervisor in charge of area to assist with investigation and correction of problem. Perform resamples and overchecks to assist in problem investigation.

+ Operate automated walkie-stacker with skids of raw materials or bulk to raw material sampling room in order to perform sampling and quality assurance evaluation of raw materials and bulks: summarize documents and report results.

+ Collect raw material samples, selected intermediates, finished package and stability samples and resamples according to SOPs.

+ Collect, sort according to active/excipient class, & transport raw material samples.

+ Perform required testing of packaging components, work in process (WIP), finished goods, and sample raw materials to ensure that approved specifications are met.

+ Utilize various instruments and equipment for qualitative and/or quantitative analysis. Calibrate equipment as required according to standard operating procedures (SOPs).

+ Using high degree of precision and accuracy, record, evaluate, report, and approve satisfactory test results into the current business operating system (i.e. LIMS, MES and/or SAP). Report all non-compliance test situations to Manager, or designee for further evaluation.

+ Monitor production schedule and collect samples for all SKUs and provide to QA Director.

+ Prepare and/or maintain records and documentation associated with samples (i.e. log book, labels) and label materials with appropriate status indicators.

+ Audit production areas, such as equipment and ancillary apparatus/materials, for cleanliness, proper identification, and suitability for processing.

+ Provide quality assurance information and training to line (PLANT) personnel through SOP interpretation, packaging line/raw material/component/warehouse issues and resolution.

+ Audit QA Logbooks monthly.

+ Review PI (Process Instructions) lists for all packaging orders and assemble orders for auditing.

+ Collect yearly stability samples for QA Stability group by assessing production schedule and expiration date, if applicable.

+ Process HOLD reports and provide information to Supplier QA for raw materials and packaging components.

+ Travel to off-site distribution center and warehouse as needed.

+ Verify segregation of materials as requested QA Documentation; and Raw Material OOS rejections as requested by QA Lab.

+ Provide monthly statistics for raw materials, packaging orders, and components.

+ Investigate and coordinate retest requests through SAP and provide results to warehouse, dispensing, PPIC and laboratory.

+ Collaborate with Packaging Supervisors to provide direction on inspection criteria for line quality issues.

+ May perform other duties as assigned.





**Qualifications:**




+ High School Diploma or equivalent **required** ; Associates degree **preferred**

+ Ability to use a respirator **required**

+ At least one-year experience in a Quality Assurance or Quality Control role **required** . QA/QC role is defined as demonstrated ability to successfully interpret and apply cGMPs in a production environment.

+ Good interpretive judgment regarding conformance of components, processes, and products required. Must be able to fluently read, write, and speak English; ability to understand verbal and written instructions.

+ Excellent organizational skills, high degree of accuracy in testing, accuracy in completing paperwork, and legible handwriting required.

+ Must have excellent interpersonal skills and have the demonstrated ability to work effectively in a team environment.

+ Demonstrated ability in written and oral communications, as well as good observation skills are required.

+ Demonstrated ability to accurately perform basic mathematics is required.

+ Demonstrated ability to adhere to safety and personal protective equipment (PPE) required.

+ Previous experience working in good manufacturing practices (GMP) and/or government regulated industry required.

+ Demonstrated ability to safely operate an automated walkie-stacker to transfer skids of raw materials and bulk in and out of raw material sampling rooms is required.

+ Knowledge of Standard Operating Procedures (SOPs), quality assurance terminology, statistical techniques, production processes, Acceptable Quality Level (AQL), and monographs /specification sheets is **preferred** .

+ Personal Computer (PC) skills required; Microsoft Office, Lotus Notes, SAP, MES experience **preferred** .






**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 interestsits 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, were always thinking about whats next and advising job seekers on new ways of working to reach their full potential. In fact, were a leading advocate for temporary/non-traditional 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 and providing accommodations for people with disabilities in all parts of the hiring process as required under its Employment Accommodation Policy. Kelly will work with applicants to meet accommodation needs that are made known to Kelly in advance.
Posted: 2020-09-25 Expires: 2020-10-26

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2nd Shift QA/QC Technician

Kelly Services
Myerstown, PA 17067

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