Quality Assurance Associate
Posted Today by SRG
Negotiable
Undetermined
Undetermined
Slough, England, United Kingdom
Summary: The QA Associate role in Slough involves working within the QA Documentation Control Team to manage the issuance of documents and labels for Manufacturing, ensuring compliance with GMP standards. The position requires maintaining documentation accuracy, performing batch consolidation duties, and liaising with internal customers to facilitate effective communication. The role emphasizes continuous improvement in QA processes and safety compliance while managing quality records and training profiles.
Key Responsibilities:
- Issuing of approved/ effective GMP documents for use in Manufacturing.
- Printing of labels for use in the Manufacturing process.
- 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.
- Co-ordinate the consolidation of all the QC testing activities.
- Perform an independent check that all relevant activities have been completed.
- Perform Batch Consolidation duties for QC Biochemistry and Microbiology testing activities.
- Liaise with internal customers to ensure receipt of required information.
- Work with QA Operations team members to improve QA quality systems/processes.
- Identify and implement improvements in safety, GMP compliance, and efficiency.
- Lead and manage quality records e.g. Deviations, CAPA, Change Controls.
- Author, review, and approve GMP documentation.
- Prioritize workload to ensure deadlines are met.
- Act as a point of contact for general queries relating to issuing.
- Maintain issuing supplies to ensure availability for on-time issuing of documents.
- Maintain the Slough archiving system according to GMP procedures.
- Maintain training profile, ensuring all required training is completed.
- Other duties as assigned.
Key Skills:
- Bachelor of Science (or equivalent experience) in Biology or related field.
- Previous work experience in QA / GMP is useful though not essential.
- 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, decision making, 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
Job title: QA Associate
Location: Slough
Contract Length: 6 months
Working Hours: 37.5 hours/week
Pay: up to 23.0 DOE
About the Role
Working as part of the QA Documentation Control Team. Proactively issue documents and labels to Manufacturing based on the schedule and defined timelines obtained from customer departments. Ensure high standard of documentation issuing are adhered to by self and others. Maintain the archiving system. Perform Batch Consolidation (auditing) duties with regard to QC Biochemistry and QC Microbiology testing activities for Drug Product (DP) and Drug Substance (DS).
Key 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 information and 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 Slough 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.
Education/experience Required:
- Bachelor of Science (or equivalent experience)- Biology or related field
- Previous work experience in QA / GMP experience is useful though not essential
- 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.