QC AnalystVacancy posted: Monday, 10 October 2016
Closing date: 07 November 2016
QC Analyst temporary role for 6 months.
Albany Molecular Research Inc. provides global contract research and manufacturing services to the pharmaceutical and biotechnology industries.
As a QC Analyst you will part of a small, customer focussed team of Analysts, this is a technical role with responsibility for completing release and stability testing on novel Drug Product formulations, and supporting Production with raw material and ‘in-process’ testing using a range of analytical methods.
As a QC Analyst, you will report to the Quality Control Supervisor and your responsibilities will include:
- The routine chemical and physical testing of raw materials used in or arising from the Company's production operations, in accordance with agreed schedules
- Particular focus on finished product testing, but will be expected to support the team in other activities as required
- To report any out of specification or out of trend results to a supervisor and to document any deviation from written analytical procedures. To liaise with production supervisors to schedule and report in-process analysis.
- To carry out stability testing of samples in accordance with the relevant procedures and cGMP.
- Ensuring that all testing is carried out within the expected time scale by setting priorities when required.
- Reporting and recording analytical results utilising authorised Quality Documentation systems, in compliance with cGMP
- Assisting in maintaining a clean working environment within the Quality Control Laboratory.
- Writing stability reports in accordance to cGMP and liaising with customers.
- Ability to develop and maintain good working relationships with colleagues.
- Testing of raw materials.
- To assist in the investigation of out of specification or out of trend results for QS.
- To operate documented systems to ensure that duties are performed to and maintain GMP standards
- To perform duties in a safe and efficient manner
- To perform and document other general laboratory duties as directed by a supervisor
Work should be performed in an organised and timely manner, adhering to client driven timelines. Additionally, duties should be performed whilst adhering to relevant GLP/GMP, COSHH and Health and Safety regulations. Good troubleshooting and communication skills are required, and the ability to interact with internal and external clients as required. Taking ownership of projects, and the ability to multi-task are also key.
- Qualified to degree level or equivalent(chemistry or related)
- Previous relevant experience within a similar laboratory environment
- Understanding of regulatory commitments, e.g. GLP. GMP, ICH, COSHH etc.
- Experience in routine HPLC (UV-VIS, CAD, IC) analysis/validation essential
- Experience in HPLC troubleshooting, maintenance and method development
- Familiar with GC, FTIR, Karl Fischer and General pharmacopeial wet Chemistry testing techniques
- Good understanding of quality control
- Customer focus
- Analytical thinking
- Organisational skills
- Working to deadline
**Please note this is a temporary role for 6 months**
Benefits package includes: Contributory pension scheme (employer up to 9%), Private Health cover after 6 months, dental and health cover voluntary schemes, childcare voucher scheme, annual gym contribution, 25 days holiday (rising to 30) plus 9 bank holidays.
If you have the relevant skills and expertise we would love to hear from you and look forward to receiving your application. Please also provide a covering letter outlining your availability and salary expectations.
AMRI provides equal employment opportunities to all individuals without regard to race, colour, religion, sex, national origin, age, disability, marital status, veteran stats, sexual orientation, citizenship, or any other characteristics protected by law. To ensure that employment decisions are consistent with equal employment opportunities, AMRI imposes only job-related requirements for these opportunities.
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