Quality Assurance Associate

Adecco US, Inc.; Winchester (KY); On-site; USD 30,000 - 43,000; Part time

Benefits offered by this job

Excellent weekly pay

401(k) plan

Health benefits

Job summary

Adecco Healthcare and Life Sciences is hiring a Quality Assurance Associate in Winchester, KY. The role supports QA activities, SOP reviews, batch record audits, and GMP compliance within a solid dosage manufacturing environment.

Location: Winchester, KY. Duration: Temp-to-hire. Pay rate: $26.38/hour. Shift: Fri, Sat, Sun 6PM–6AM with overtime as needed.

Qualifications

• BS degree or an Associate's with 1 year of related work experience OR HS Diploma/GED with 2 years of related work experience.
• Candidate should have related QA exposure and be able to review SOPs and batch records.

Responsibilities

• 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 and conformance to parameters.
• Perform room and equipment clearances following cleaning.
• Perform microbial swabbing for environmental monitoring.
• Maintain understanding of cGMP and CFR guidance for solid dosage manufacturing.
• Perform in-process and finished product testing and monitoring of production areas.
• Initiate deviation reports in TrackWise with detailed incident information.
• Manage quality status of WIP and finished goods in inventory systems.
• Assist investigations for deviations and root cause analysis.

Skills

Quality Assurance

SOP documentation

Education

BS degree or Associate's with 1 year of related work experience

HS Diploma/GED with 2 years of related work experience

Tools

TrackWise

JD Edwards

Job description

Adecco Healthcare and Life Sciences is hiring for a Quality Assurance Associate in Winchester, KY.

Location: Winchester, KY

Duration: Temp-to-hire

Pay rate: $ 26.38/hour

Shift: SHIFT - FRI, SAT, SUN 6PM - 6AM + 1 DAY EVERY OTHER WEEK + MANDATORY OVERTIME.

Job details for this position include:

• 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 Catalent 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 teamwork and good communication.
• Provide training and coaching to manufacturing staff as needed
• Support site process improvements (training, efficiency projects, implementation of CAPAs)
• Completes investigations of customer complaints

Qualifications for this position include:

• BS degree or Associates with 1 year of related work experience
• or HS Diploma/GED with 2 years of related work experience

Why work for Adecco?

• Excellent Weekly Pay
• 401(k) Plan
• Skills Training
• Excellent medical, dental, and vision benefits

Benefit offerings include medical, dental, vision, life insurance, short-term disability, additional voluntary benefits, EAP program, commuter benefits and 401K plan. Our program provides employees the flexibility to choose the type of coverage that meets their individual needs. Available paid leave may include Paid Sick Leave, where required by law; any other paid leave required by Federal, State, or local law; and Holiday pay upon meeting eligibility criteria.

IMPORTANT: This position is being recruited for by Adecco’s Healthcare & Life Sciences division, not your local Adecco Branch Office.

Equal Opportunity Employer/Veterans/Disabled.

The Company will consider qualified applicants with arrest and conviction record

Pay Details: $26.38 per hour

Benefit offerings available for our associates include medical, dental, vision, life insurance, short-term disability, additional voluntary benefits, EAP program, commuter benefits and a 401K plan. Our benefit offerings provide employees the flexibility to choose the type of coverage that meets their individual needs. In addition, our associates may be eligible for paid leave including Paid Sick Leave or any other paid leave required by Federal, State, or local law, as well as Holiday pay where applicable.

Equal Opportunity Employer/Veterans/Disabled

The Company will consider qualified applicants with arrest and conviction records in accordance with federal, state, and local laws and/or security clearance requirements, including, as applicable:

• The California Fair Chance Act
• Los Angeles City Fair Chance Ordinance
• Los Angeles County Fair Chance Ordinance for Employers
• San Francisco Fair Chance Ordinance

Massachusetts Candidates Only:

It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability.