Quality Assurance Associate
Posted Today by SRG
Negotiable
Undetermined
Undetermined
Slough, England, United Kingdom
Summary: The Quality Assurance Associate role in Slough involves ensuring compliance with GMP standards through the issuance and management of documentation and labels for manufacturing processes. The position requires coordination of QC testing activities, independent checks of specifications, and collaboration with internal teams to enhance QA systems. The associate will also be responsible for maintaining training profiles and managing quality records while prioritizing workload to meet deadlines.
Key Responsibilities:
- Issuing approved/effective GMP documents for Manufacturing.
- Printing labels for the Manufacturing process.
- Checking accuracy of issued documentation and labels.
- Issuing effective logbooks according to GMP procedures.
- Coordinating QC testing activities.
- Performing independent checks on release specifications.
- Conducting Batch Consolidation duties for QC testing activities.
- Liaising with internal customers for required information.
- Working with QA Operations team for process improvements.
- Identifying and implementing improvements in safety and efficiency.
- Managing quality records such as Deviations and CAPA.
- Authoring, reviewing, and approving GMP documentation.
- Prioritizing workload to meet deadlines.
- Acting as a point of contact for issuing queries.
- Maintaining issuing supplies for timely document issuance.
- Maintaining the archiving system according to GMP procedures.
- Ensuring completion of required training prior to activities.
- Other duties as assigned.
Key Skills:
- IT literate (MS Office – Word, 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.