ONSITE POSITION - TEMP TO HIRE - DURATION - 3 MONTHS - MON-FRI - 2PM-10 : 30PM
I. Position Overview :
The QA Associate is responsible for the Quality support functions associated with the manufacturing
of solid oral dosage products for a given business unit. The essential responsibilities associated with
this position are oversight of the manufacturing operations (as dictated by cGMP, CFR, and Catalent
SOP) through document review / approval, real time monitoring / approval of manufacturing activities
and testing / approval of in-process and finished product samples.
II. Specific Tasks, Duties and Responsibilities :
RESPONSIBILITIES INCLUDE, BUT ARE NOT LIMITED TO :
- Recommend SOP and batch record changes as needed
- Review proposed SOP revisions and provide feedback to management
- Real-time audit of batch records in the production suites for completeness, documentation,
calculation errors and conformance to critical process parameters
Perform room and equipment clearances per procedure following cleaning conducted byproduction.
Perform microbial swabbing of equipment and room surfaces for environmental monitoring.Maintain a full understanding of all Catalent SOPs and policies along with all cGMP and CFRguidance that are applicable to the manufacturing of solid oral dosage pharmaceutical
products.
Perform routine testing of in-process and finished product samples including particle size, bulkdensity, moisture analysis, appearance, and AQL testing real-time.
Monitor production manufacturing areas for compliance to SOP / cGMP / batch record and safetyrequirements in order to identify and resolve routine errors and prevent possible deviations
that affect production real-time.
Works cross functionally to assess impact for potential deviations and assist in identifying if aninvestigation is required.
Initiate deviation problem reports in Trackwise for issues discovered by QA, providingsufficient detail of the incident so that a full investigation by the responsible department can be
conducted.
Manage quality status of WIP and finished good materials on physical inventory and ininventory system (JD Edwards)
Other assignments as needed within the scope of QA Associate training curriculum.Assist in investigations for deviations by supporting data gathering and root cause analysisEnforcement of GMP Compliance.Promotes team work and good communication.Provide training and coaching to manufacturing staff as neededSupport site process improvements (training, efficiency projects, implementation of CAPAs)Supports customer complaint investigation by performing inspection of retains and complaintsamples
III. Essential Skills and Experience :
Education or Experience :
Bachelor's Degree in related science or technical field preferred with 2 years prior workexperience
Minimum of High School Diploma with 4 years of relevant experience in a regulated GMPmanufacturing environment.
Additional qualifications desired are Lean Six Sigma, ASQ certification or other professional certification.Knowledge / Skills Requirements :
Familiarity with basic laboratory instrumentationSafe work habitsBasic math and computer skillsGood communication skillsAbility to follow written and verbal instructionsAble to work with limited supervision for routine tasksExcellent documentation and handwriting skillsProficient reading and comprehension skillsSound decision-making, technical and problem-solving skillsGood time management skillsExpert technical writing and problem-solving skillsGood Laboratory PracticesExperienced with continuous improvement techniquesEEO :
Mindlance is an Equal Opportunity Employer and does not discriminate in employment on the basis of - Minority / Gender / Disability / Religion / LGBTQI / Age / Veterans."
