Quality Assurance Associate

Quality Assurance Associate

Posted 6 days ago by SRG

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Negotiable
Undetermined
Undetermined
Slough, England, United Kingdom
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Consolidation Data Entry DMS Software Reengineering Toolkits Email Archiving Management Microsoft Excel Microsoft Office Microsoft Word Prioritisation Scheduling

Summary: The Quality Assurance Associate role in Slough involves ensuring compliance with GMP standards through the issuance and management of documentation, labels, and logbooks. The position requires coordination of QC testing activities and collaboration with internal teams to enhance QA processes. The associate will also be responsible for maintaining training profiles and managing quality records. This role demands strong organizational skills and attention to detail to meet strict deadlines.

Key Responsibilities:

  • Issuing approved/ effective GMP documents for use in Manufacturing.
  • Printing labels for use in the Manufacturing process.
  • Checking accuracy of issued documentation and labels.
  • Issuing effective logbooks as required according to GMP procedures.
  • Coordinating the consolidation of all QC testing activities.
  • Performing independent checks to ensure all release specifications are met.
  • Performing Batch Consolidation duties for QC Biochemistry and Microbiology testing activities.
  • Liaising with internal customers to ensure receipt of required information.
  • Working with QA Operations team members to improve QA quality systems/processes.
  • Identifying and implementing improvements in safety, GMP compliance, and efficiency.
  • Leading and managing quality records such as Deviations, CAPA, Change Controls, Investigations.
  • Authoring, reviewing, and approving GMP documentation.
  • Prioritizing workload to ensure deadlines are met.
  • Acting as a point of contact for general queries relating to issuing.
  • Maintaining issuing supplies to ensure availability of materials.
  • Maintaining the archiving system according to GMP procedures.
  • Maintaining training profile to ensure all required training is completed.
  • Other duties as assigned.

Key Skills:

  • IT literate (MS Office – Word, Explorer, Excel, Access, Outlook).
  • Familiarity with database entries.
  • Verbal and written communication skills.
  • Risk-based decision making.
  • PQS experience.
  • Accurate data entry skills with high attention to detail.
  • Demonstrated workload prioritization and scheduling skills.
  • Ability to meet strict deadlines.
  • Good organizational and planning skills.

Salary (Rate): undetermined

City: Slough

Country: United Kingdom

Working Arrangements: undetermined

IR35 Status: undetermined

Seniority Level: undetermined

Industry: Other

Detailed Description From Employer:

Job Title –Quality Assurance Associate

Location –Slough

Contract Length – initial 6 months

Pay Rate- 23.06 is max rate – depending on experience

Roles and Responsibilities

  • Issuing of approved/ effective GMP documents for use in Manufacturing (entering the unique document ID based on the issue list, printing from DMS and signing the issue list) ensuring that Manufacturing deadlines are met.
  • Printing of labels for use in the Manufacturing process, including finished product labels.
  • Checking accuracy of issued documentation and labels
  • Issuing of effective logbooks as required according to GMP procedures.
  • Printing and issuing other GMP documentation as required meeting business timelines
  • Co-ordinate the consolidation of all the QC testing activities
  • Perform an independent check that all the relevant activities have been completed and all release specifications have been met.
  • Perform Batch Consolidation duties with regard to QC Biochemistry and Microbiology testing activities for Drug Product and Drug Substance.
  • Liaise with internal customers to ensure receipt of required informationand maintain effective interdepartmental communication and collaboration.
  • Work with the QA Operations team members, Manager and Team Leaders to enable continued improvement to QA quality systems / processes.
  • To continually identify and implement improvements in safety, GMP compliance and efficiency.
  • Leading and management of quality records e.g. Deviations, CAPA, Change Controls, Investigations
  • Authoring, Reviewing and approving GMP documentation
  • Prioritizing workload to ensure deadlines are met.
  • Acting as a point of contact for general queries relating to issuing.
  • Maintenance of issuing supplies to ensure that materials are always available to enable on time issuing of documents.
  • Maintenance the archiving system by checking received boxes adhere to GMP procedures, arranging for box collection and coordinating box retrieval as required.
  • Maintenance of training profile, ensuring that all required training is completed prior to performing an activity.
  • Other duties as assigned.

Skills Required

  • IT literate (MS Office – Word, Explorer, Excel, Access, Outlook) familiarity with database entries
  • Verbal and written communication skills
  • Risk based decision making
  • PQS experience
  • Accurate data entry skills, high attention to detail
  • Demonstrated workload prioritization skills, decision making and scheduling skills
  • Ability to meet strict deadlines
  • Good organizational and planning skills.
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