QA Associate

Job Title: QA Associate

Location: Slough, UK

Duration: 6 Months Contract

Job Description:

Scope & Role purpose:

• 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.
• Perform Batch Consolidation (auditing) duties with regard to QC Biochemistry and QC Microbiology testing activities for Drug Product (DP) and Drug Substance (DS).

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 of training profile, ensuring that all required training is completed prior to performing an activity.
• Other duties as assigned.

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, high attention to detail
• Demonstrated workload prioritization skills, decision making and scheduling skills
• Ability to meet strict deadlines
• Good organizational and planning skills.

Qualifications :

Required - Bachelors of Science (or equivalent experience) Biology or related field

Competencies:

• Agility • Demonstrates an ability and desire to learn from experience • Treats errors as a learning opportunity • Is willing to take on new challenges • Takes steps to adapt thinking and behavior to support change
• Business Acumen • Seeks to understand the corporate strategy and how his/her business area contributes to the company’s success • Understands the impact of his/her own actions on his/her business area • Expresses ideas that will improve his/her business area • Uses knowledge of his/her business area to make accurate and timely decisions
• Collaboration • Works as an active member of his/her team • Generously shares information and knowledge with others on the team • Demonstrates an openness to different perspectives by balancing listening and speaking • Treats all co-workers and customers professionally and with respect
• Customer Focus • Understands what internal and/or external customers need from him/her to deliver in his/her respective role • Demonstrates an openness to receiving customer feedback • Takes action to enhance customer satisfaction within the scope of his/her role
• Driving Results • Consistently delivers goals while monitoring KPIs with supervisor • Demonstrates persistence and motivation to overcome obstacles and challenges • Ensures quality standards are maintained while delivering results • Plans, prioritises and organises work to deliver on time
• Leadership • Takes responsibility for his/her safety and that of others • Takes responsibility for personal choices and behaviours • Seeks feedback and reflects on his/her development needs in order to continuously improve • Contributes to a positive work environment • Acts as a reliable and dependable member of the team

Note : Previous work experience in QA / GMP experience is useful though not essential

Other Requirements

• Quality : Utilising knowledge of quality procedures to identify and report non-conformances and resolve issues arising in the area via interaction with the relevant personnel. Obtaining confirmation on any issue of which unsure
• Safety : Maintaining a safe working environment for self and all employees. Actively identifying potential safety risks and working to mitigate these.