QA Associate 1

Mindlance; Winchester; On-site; GBP 35,000 - 45,000; Full time

Job summary

A pharmaceutical company is seeking a QA Associate in Winchester to oversee quality support functions in manufacturing solid oral dosage products. Responsibilities include ensuring compliance with cGMP, reviewing batch records, performing real-time audits, and assisting in investigations for deviations. The ideal candidate will possess a Bachelor's Degree in a scientific field or a High School Diploma with extensive experience in a regulated GMP environment. Strong communication and documentation skills are essential for this role.

Qualifications

• Bachelor’s Degree in a related field and 2 years of relevant experience preferred.
• Minimum 4 years experience in regulated GMP manufacturing required.

Responsibilities

• Oversee manufacturing operations through document review and approval.
• Perform real-time audits of batch records for compliance.
• Monitor production areas for adherence to safety and quality requirements.
• Assist in investigations for product deviations.

Skills

Good communication skills

Basic math and computer skills

Safe work habits

Excellent documentation and handwriting skills

Sound decision-making, technical and problem-solving skills

Time management skills

Familiarity with basic laboratory instrumentation

Proficient reading and comprehension skills

Demonstrates initiative

Education

Bachelor’s Degree in related science or technical field

High School Diploma with 4+ years relevant work experience

Job description

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.

Specific Tasks, Duties and 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, 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 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

• 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

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
• Demonstrates initiative

EEO

“Mindlance is an Equal Opportunity Employer and does not discriminate in employment on the basis of – Minority/Gender/Disability/Religion/LGBTQI/Age/Veterans.”