Quality Control Analyst

Role: Quality Control Analyst
Duration: 6 Months
Location: 110 Crossways Boulevard Crossways Dartford, DA2 6QY

Release Perform analytical testing in an accurate, timely and efficient manner, consistent with cGMP requirements.
Testing may include but is not limited to, routine particle size analysis, cleaning verification, identification testing Fourier-transform infrared spectroscopy (FTIR), method development and validation (including particle size and cleanability assessments, differential scanning calorimetry (DSC), Surface Area Analysis, method optimisation and trouble-shooting, technology transfer and pharmacopoeia analyses as appropriate.
Ensure documentation is accurate, legible and presented clearly and concisely, consistent with cGMP requirements.
Prepare test methods for particle size analysis and cleaning verification analysis.
Prepare analytical test reports for submissions to clients or the Company's other departments.
These include, but are not limited to, Statement of Results, Certificate of Analysis and Cleaning Certificates The Candidate Particle size analysis knowledge/experience would be an advantage HPLC Method Development and Validation is desirable Degree in a Scientific, Biotech or similar subject required or equivalent experience.
Knowledge of GMP

Specific Activities, and Responsibilities:
Accurately Completes documentation related to the Encapsulation process.
Operates and maintains up to two Encapsulation Machines (and covers up to as many as four during breaks). Maintains a clean work area. Performs in-process checks and evaluates, in detail, product quality.
Monitors material and gel usage at the machine and changes receivers as needed ensuring that components are not used past expiration date and time.
Ensures empty receivers are transported back to respective departments as soon as possible.
Monitors encapsulation process to minimize rejected product at the machine. Coordinates with crib mechanic in advance of and during changeover.
Tears down machine at changeover if required (if utility unavailable) Sets-up/assembles Encapsulation Machine for operation per batch record instructions (if utility unavailable) within allotted time per department standards.
Troubleshooting Equipment to maintain a quality product.
Monitors and replenishes solvents and lubricants as required. Assembles, handles, and stages tray stacks with manufactured softgels.
Ensures that needed supplies (tray paper, gloves etc.) for the department are maintained at sufficient levels. Handles non-hazardous, hazardous and DEA materials and waste.
Performs work according to safety policies and practices related to the position.
Notifies Supervision immediately in the event that there is any deviation from the batch record, SOP or potential production event.
Update SOPs for assigned department as needed.

Utility - Supports Encapsulation Operators during the manufacturing process by; Completes documentation related to the Encapsulation process during a changeover.
Coordinates with crib mechanic in advance of and during changeover Tears down machine at changeover.
Sets-up/assembles Encapsulation Machine for operation per batch record instructions.
Monitors encapsulation process to minimize rejected product at the machine. Operates Encapsulation Machine, if required.
Helps to maintain a clean work area on the encapsulation floor. Performs in-process checks and evaluates product quality.
Assists operators with material and gel receiver changes as necessary - Ensures empty receivers are transported back to respective departments.
Assembles, handles, and stages tray stacks with manufactured softgels.
Individual's primary Workstation is located in the manufacturing area, where the noise level is high.
Work schedule may include 12-hours shift, days, nights and/or weekends including overtime as required.
Some exposure to industrial chemicals and detergents.
Some handling of flammable materials and potent drug compounds