Quality Assurance Specialist Job at Acro Service Corp, Winchester, KY

Y0ZTSXVvZnE0NzVyNU1URm9qaUUwbVprdlE9PQ==
  • Acro Service Corp
  • Winchester, KY

Job Description

Job Title : QA Associate

Regular Hours (SHIFTS)

1. MON-FRI 6AM - 2:30PM.

2.FRI, SAT, SUN 6PM - 6AM.

3. FRI, SAT, SUN 6AM - 6PM.

Duration- 6 Months (Contract To Hire)

MAJOR DUTIES:

• 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

Education Requirements

Education or Experience: (Minimum required to perform job)

• Preferred - Bachelor’s Degree in related science or technical field in combination with 2 years prior relevant work experience.

• Minimum of High School Diploma in combination with 4+ years of relevant work experience in a regulated GMP manufacturing environment.

• Additional qualifications desired are Lean Six Sigma, ASQ certification or other professional certifications.

Job Tags

Contract work, Work experience placement, Shift work,

Similar Jobs

Union Home Mortgage Corp.

Area Sales Manager Job at Union Home Mortgage Corp.

 ...Job Title: Area Sales Manager Department: Sales and Growth Location: Determined by Area Responsible To: Regional Manager Overview: Hire, train and direct the Sales Force in order to achieve the operations new growth and production goals while operating... 

Pocketbook Agency

In-home Lifestyle Management and House Manager Job at Pocketbook Agency

 ...is seeking an experienced, detail-oriented In-Home Lifestyle Manager & House Manager to oversee the daily operations of their primary...  ...needs. Requirements: ~10+ years of experience in private home or lifestyle management for UHNW individuals or families.... 

Onward Search

Physical Therapist [77258] Job at Onward Search

Onward Search is excited to partner with a school in Mercer County, New Jersey , to find a passionate and dedicated Physical Therapist . This impactful, part-time role begins ASAP and will continue through the remainder of the school year. Details You Should Know...

Global Elite Group

Recruiting Intern Job at Global Elite Group

 ...Preparing recruiting metrics and reports Providing administrative support to the recruiting and HR teams Qualifications College student Strong communication and organizational skills Ability to multitask in a fast-paced, deadline-driven environment... 

BCG Attorney Search

Mid-Level Real Estate Attorney - Institutional Investments & Complex Transactions | Washington, D.C.- 377098 Job at BCG Attorney Search

 ...Job ID: 377098 Practice area:- Real Estate - Commercial Transactions,Real Estate - Finance...  ...for institutional investors and private equity clients. Work on complex financings...  ...level attorneys with 35 years of experience managing commercial real estate transactions on behalf...