Talent.com
Alltech Consulting Services
QA AssociateAlltech Consulting Services • Winchester
QA Associate

QA Associate

Alltech Consulting Services • Winchester
30+ days ago
Job type
  • Full-time
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 Company’s 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:
• 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 Company’s 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

III. Essential Skills and Experience:
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.

Knowledge/Skills Requirements: (List unique knowledge skills, or problem-solving 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
Create a job alert for this search

QA Associate • Winchester

Similar jobs

Health & Safety Consultant, Associate

Ridge & Partners LLPMidgham, ENG, GB
Full-time

We are recruiting for an experienced CDM / Health & Safety professional to join our team in the Reading office.For this role you have a sound understanding of the Construction (Design and Manag... Show more

 • Promoted

Senior QA Automation Engineer: Build Scalable Frameworks

developFareham, England, GB
Full-time

A digital fitness app company in Fareham is seeking a Senior QA Automation Engineer to establish automation frameworks and strategies.This role involves leading automation efforts for mobile and we... Show more

 • Promoted

Senior Quality Engineer

Latitude RecruitmentFareham, England, United Kingdom
Full-time

Our clients, based close to Fareham, have an exciting opportunity for a Senior Quality Engineer to join their growing team.Duties & Responsibilities: Record and categorise non-conformities.Find roo... Show more

 • Promoted

Quality Engineer – ISO/Nuclear QA & Process Excellence

Hythe Group Ltd.Fareham, England, GB
Full-time

Hythe Engineering in Fareham is seeking a Quality Engineer to ensure the quality and integrity of our components.You will inspect with equipment, document findings, and contribute to improving insp... Show more

 • Promoted

Quality Engineer: QMS & Continuous Improvement Lead

Jackie Kerr Recruitment - Engineering and ManufacturingAndover, England, GB
Full-time

Jackie Kerr Recruitment - Engineering and Manufacturing seeks an experienced Quality Engineer for a busy precision engineering company.The role focuses on implementing QHSE with a hands-on approach... Show more

 • Promoted

Senior MRICS QS | Hybrid, 38 Days Leave, Path to Associate

Stafford LawrenceWinchester, England, GB
Full-time +1

Job Vacancy: Senior MRICS Cost Consultant Quantity Surveyor.Winchester, Hampshire £50,000 - £60,000 + 38 Days Leave & Hybrid Flexibility.Ready to advance your career with a consultancy that priorit... Show more

 • Promoted

Quality Assurance Engineer

More To MotorFareham, England, GB
Full-time

Monday to Thursday, 8:00am – 4:30pm; Friday, 8:00am – 1:00pm.Up to £45,000 + 10% Bonus + Benefits.Support certified aerospace development projects across the full product lifecycle, ensuring compli... Show more

 • Promoted

Aerospace Quality Assurance Engineer – Certification & Compliance

More To MotorFareham, England, GB
Full-time

More To Motor is seeking a Quality Assurance Engineer based in Fareham.This role involves supporting aerospace development projects across the product lifecycle and ensuring compliance with relevan... Show more

 • Promoted

Audit Quality & M&A Transactions Lead (Hybrid)

TC GroupFareham, England, GB
Full-time

TC Group in Fareham is seeking an Audit Quality & Transactions Lead to enhance audit quality and support M&A activities.This is a hands-on, high-impact role focused on audit due diligence and post-... Show more

 • Promoted

Business Hub Support Associate

National Oceanography CentreSouthampton, England, GB
Full-time

Business Hub Support Associate.We are the National Oceanography Centre (NOC) - the UK’s leading institution for integrated coastal and deep ocean research.Through our ground-breaking research, coll... Show more

 • Promoted

Associate Consultant

VICTORIA WALL ASSOCIATES LIMITEDWest End, England, GB
Permanent +1

Associate Consultant at VWA – Boutique Recruitment Consultancy – Up to £35k depending on experience – West End – VWAAC/NCW – VWA is hiring! We are looking for an ambitious and curious Associate Con... Show more

 • Promoted

Senior Quality Assurance Automation Engineer

developFareham, England, GB
Permanent

Hybrid – Portsmouth/Southampton – flexible on how often you need to be in the office.A fast-growing digital fitness and wellbeing app is looking to hire its first Senior QA Automation Engineer to e... Show more

 • Promoted

Associate Architect or Technologist

Morson EdgeWinchester, GB
Full-time

Morson Group are seeking an experienced Associate Architect or Associate Technologist to join a Winchester office.This is an excellent opportunity for someone with a strong track record of deliveri... Show more

 • Promoted

Senior Software Tester

Context RecruitmentSouthampton, England, GB
Full-time

Senior Software Tester / QA Engineer – Up to £44,000 PA.We are working with a well-established technology organisation to recruit an experienced Senior Software Tester / QA Engineer to play a key r... Show more

 • Promoted

Quality Engineer

WR EngineeringWinchester, England, GB
Full-time +1

You will support project delivery by overseeing quality assurance, supplier quality activities, inspections and compliance across fabrication, welding, testing and installation activities.Working c... Show more

 • Promoted

Associate Consultant — Hybrid/Remote + Growth Path

VICTORIA WALL ASSOCIATES LIMITEDWest End, England, GB
Remote
Full-time

VICTORIA WALL ASSOCIATES LIMITED, located in the West End, is seeking an ambitious Associate Consultant to support various recruitment searches.This role offers significant growth potential and inv... Show more

 • Promoted

Quality Engineer: Data-Driven QA & Validation Lead

CooperVisionFareham, England, GB
Full-time

CooperVision in Fareham, Hampshire, seeks a Quality Engineer to join the Packaging and Distribution Quality Engineering Team.You will ensure that all activities meet the Quality System requirements... Show more

 • Promoted

Associate / Senior Associate

Trethowans LLPSouthampton, England, GB
Full-time

Associate / Senior Associate - Corporate.As part of our strategic growth plans, we are seeking an experienced Corporate Solicitor to join our highly regarded Corporate Team, based in either our Sou... Show more

 • Promoted

Senior Software Assurance Consultant – AI‑Driven Quality (Contract)

Curo Resourcing Ltd.Brimpton, England, GB
Full-time

Our client seeks a Senior Software Assurance Consultant to perform an independent, end-to-end review of the software development lifecycle, governance and AI-assisted engineering practices.Onsite c... Show more

 • Promoted

Quality Assurance Lead — ISO & Right-First-Time

Jobs for HumanitySouthampton, England, GB
Full-time +1

Jobs for Humanity is collaborating with Kier to seek a Quality Manager based in Southampton.The role focuses on supporting the Southern Region with quality assurance compliance across projects.You ... Show more