QA Associate 1

5 hours ago

Winchester, United States Hire Talent Full time
Job Title: QA Associate 1
Job Location: Winchester, KY
Job Duration: 3+ Months (Temp to Hire)
Shift time: Mon-Fri 2PM-10:30PM

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 *** SOP) through document review/approval, real time monitoring/approval of manufacturing activities and testing/approval of in-process and finished product samples.

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 by
production.
• Perform microbial swabbing of equipment and room surfaces for environmental monitoring.
• Maintain a full understanding of all *** SOPs and policies along with all cGMP and CFR
guidance 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, bulk density, moisture analysis, appearance, and AQL testing real-time.
• Monitor production manufacturing areas for compliance to SOP/cGMP/batch record and safety requirements 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 an investigation is required.
• Initiate deviation problem reports in Trackwise for issues discovered by QA, providing
sufficient 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 in
inventory 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 analysis
• Enforcement of GMP Compliance.
• Promotes team work and good communication.
• Provide training and coaching to manufacturing staff as needed
• Support site process improvements (training, efficiency projects, implementation of CAPAs)
• Supports customer complaint investigation by performing inspection of retains and complaint samples

Essential Skills and Experience:
Education or Experience:
• Bachelor's Degree in related science or technical field preferred with 2 years prior work experience
• Minimum of High School Diploma with 4+ years of relevant experience in a regulated GMP manufacturing environment.
• Additional qualifications desired are Lean Six Sigma, ASQ certification or other professional certification.
Knowledge/Skills Requirements:
• Familiarity with basic laboratory instrumentation
• Safe work habits
• Basic math and computer skills
• Good communication skills
• Ability to follow written and verbal instructions
• Able to work with limited supervision for routine tasks
• Excellent documentation and handwriting skills
• Proficient reading and comprehension skills
• Sound decision-making, technical and problem-solving skills
• Good time management skills
• Expert technical writing and problem-solving skills
• Good Laboratory Practices
• Experienced with continuous improvement techniques

  • QA Associate 1

    2 months ago

    Winchester, United States Mindlance Full time

    SHIFT - MON-FRI 2PM - 10:30PM. 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 *** SOP) through document...

  • QA Associate 1

    2 months ago

    Winchester, United States Aditi Consulting Full time

    Summary: 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 company SOP) through document review/approval, real time...

  • QA Associate 1

    21 hours ago

    Winchester, United States Mindlance Full time

    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...

  • QA Associate 1

    1 hour ago

    Winchester, United States Aditi Consulting Full time

    Payrate: $24 - $26/hr. Summary: 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 company SOP) through document...

  • QA Associate

    19 hours ago

    Winchester, United States Ampcus Full time

    Ampcus Inc. is a certified global provider of a broad range of Technology and Business consulting services. We are in search of a highly motivated candidate to join our talented Team. Job Title: QA Associate Location(s): Winchester, KY (40% - Onsite Position MON-FRI - 2PM-10:30PM) I. Position Overview: The QA Associate is responsible for the Quality support...

  • QA Associate KY

    3 days ago

    winchester, United States BCforward Full time

    QA AssociateBCforward is currently seeking a highly motivated QA Associate in Winchester, KY 40391 Job Title: QA Associate Duration: 3 + Months (Temp to Hire)Location: Winchester, KY 40391 Anticipated Start Date: 1/20/2025(Please note this is the target date and is subject to change. BCforward will send official notice ahead of a confirmed start date.) Job...

  • BCforward | QA Associate KY

    1 day ago

    winchester, United States BCforward Full time

    QA AssociateBCforward is currently seeking a highly motivated QA Associate in Winchester, KY 40391 Job Title: QA Associate Duration: 3 + Months (Temp to Hire)Location: Winchester, KY 40391 Anticipated Start Date: 1/20/2025(Please note this is the target date and is subject to change. BCforward will send official notice ahead of a confirmed start date.) Job...

  • QA Associate

    3 days ago

    Winchester, United States BCForward Full time

    Job DescriptionJob DescriptionJob Title: QA AssociateDuration: 3 + Months (Temp to Hire)Location: Winchester, KY 40391Anticipated Start Date: 1/20/2025(Please note this is the target date and is subject to change. BCforward will send official notice ahead of a confirmed start date.)Job Type: Contract (40 hrs. a week)Position Overview:The QA Associate is...

  • Parts Specialist-1

    3 weeks ago

    Winchester, United States O'Reilly Auto Parts Full time

    O'Reilly Automotive - 930 E Greenville Pike [Sales Associate / Team Member] As a Parts Specialist at O'Reilly Automotive, you'll: Deliver excellent customer service and ensure a positive customer experience; Support management in the accomplishment of assigned tasks; Maintain inventory control and store appearance; Demonstrate knowledge and passion for...

  • Environmental Services

    1 month ago

    WINCHESTER, United States Sodexo Full time

    Unit Description: Sodexo is seeking a Environmental Service Operation Manager 1, at Winchester Hospital, located in Winchester Massachusetts.  This is a 169 bed acute care facility. There are 70 Full time hospital paid staff. This is the area's most prominent Obstetric and Pediatric hospital, with more than 2000 babies born each year. This is a 2nd shift...

  • Sales Associate

    7 months ago

    Winchester, United States Buettner Tire Distributors Full time $35,000 - $50,000

    Buettner Tire in Winchester is looking for a full time sales associate.  Job Details: Retail experience is a must.  Experience in the automotive field is a plus but not mandatory.  Must have positive attitude and work well in a team environment.  Hours are Monday to Friday 7:30-5:00 and every other Saturday 7:30-1:00.

  • Retail Associates

    3 months ago

    Winchester, United States JobGet Staffing Full time

    Immediate Openings! We are currently accepting applications for seasonal positions! We offer exciting career opportunities for bright, energetic and talented individuals in a stimulating, fast-paced and team-oriented culture. JobGet Staffing is a world worth exploring - where dedication and achievement are rewarded.Starting seasonal range - $13.00 - $14.00...

  • Registered Nurse

    1 week ago

    Winchester, United States SimplyApply Full time

    DepartmentCRITICAL CARE 1 - 206128Worker Sub TypeRegularWork ShiftThird Shift (United States of America)Pay GradeJob DescriptionThe registered professional nurse is responsible for utilizing job skills to effective carry out the nursing process: including assessment, diagnosis, outcomes identification, planning, evaluation, documentation and time management....

  • Sales Associate

    3 weeks ago

    Winchester, Nevada, United States Buettner Tire Distributors Full time

    Buettner Tire Distributors, a leading provider of tire products in the Winchester area, is seeking a highly motivated Sales Associate to join their team. As a key member of the sales department, this individual will be responsible for driving revenue growth and delivering exceptional customer experiences.About Buettner Tire DistributorsOur company has been a...

  • Sales Associate

    6 months ago

    Winchester, United States Chico's Full time

    Join our chic team, dedicated to a styling and social experience that inspires women to express their individuality. POSITION OBJECTIVE: The Sales Associate is responsible for supporting Management in in promoting a customer and product-focused sales culture, where our values and guiding principles are at the forefront of all store operations, including...

  • Assistant/Associate Director for On-Campus Experience

    3 weeks ago

    Winchester, United States Shenandoah University Full time

    Shenandoah University's Office of Admissions is accepting applications for an Assistant/Associate Director for On-Campus Experience. This is a full-time benefited position located on our main campus in Winchester, Virginia. The successful candidate will lead a dynamic admissions team dedicated to crafting exceptional campus experiences that showcase the...

  • Regional Service Associate II

    2 weeks ago

    Winchester, United States Eastern Bank Full time

    Starting Rate: $24.00 Primary Location: Winchester MA The Regional Service Associate serves as a vital member of our retail banking network. They will have the unique opportunity to work several branches within their region, offering short-term to long-term support as needed. This role is responsible for operational compliance and adherence to policy....

  • Regional Service Associate II

    2 weeks ago

    Winchester, United States Eastern Bank Full time

    Starting Rate: $24.00 Primary Location: Winchester MA The Regional Service Associate serves as a vital member of our retail banking network. They will have the unique opportunity to work several branches within their region, offering short-term to long-term support as needed. This role is responsible for operational compliance and adherence to policy....

  • Environmental Services

    4 weeks ago

    WINCHESTER/Massachusetts/US Sodexo Full time

    Unit Description: Sodexo is seeking a Environmental Service Operation Manager 1, at Winchester Hospital, located in Winchester Massachusetts.  This is a 169 bed acute care facility. There are 70 Full time hospital paid staff. This is the area's most prominent Obstetric and Pediatric hospital, with more than 2000 babies born each year. This is a 2nd shift...

  • Bakery Associate

    4 weeks ago

    Winchester, United States The GIANT Company Full time

    Address: USA-VA-Winchester-200 Rivendell Court Store Code: GC - Store Mgrs (2600610) At The GIANT Company we‘re committed to making our stores and facilities better every day for our team members, customers, and communities. It‘s our secret recipe for success and it guides everything we do. We put our customers first, do what‘s right, win together, and...