Temp QC Sample Management : Perform a wide variety of duties to support chain of custody for raw material, utilities, in-process and bulk drug substance manufacture in a cGMP regulatory environment.
Essential Duties and Responsibilities; include, but are not limited to, the following:
- Oversees and maintains appropriate procedures to ensure chain of custody for QC samples is maintained.
- Ensures a high level of customer service for teams submitting samples for QC, including customer queries.
- Participation in cross functional site meetings.
- Technical writing assignments such as SOPs, protocols, final reports, trend reports, risk assessments, laboratory investigations, etc.
- Participates in training of other new employees and prioritizes workloads on a daily basis.
- May enter a Laboratory Cleanroom to collect and log samples for analysis.
- May perform analysis in accordance with standard operating procedures (SOPs).
- Ensures that all work carried out is in compliance with the required regulatory standards, conforms to company policies and standard operating procedures (SOPs).
- Completes own test records on time and peer reviews data from other analysts for accuracy and completeness.
- Conducts laboratory investigations and generates reports in response to invalid assays, Deviations, OOS/OOT.
- Initiates and completes CAPAs and Change Controls in accordance with site procedures.
- Writes new and updates current SOPs as needed.
- Provides training to other analysts in the QC group.
- Presents analytical data reports clearly and concisely to management.
- Proactively identifies and implements lab process improvements, lean initiatives.
- Performs other duties relevant to the QC laboratory position as required.
Education and Experience:
- Certificate / Diploma in a scientific/technical discipline.
- 1 – 2 years hands-on work experience in a regulated QC laboratory within the biopharmaceutical industry.
- Experience with electronic systems such as LIMS, Qumas, eDoc, Trackwise etc., is an advantage.
- Excellent communication skills, both verbal & written.
- Adaptable and flexible, willing to travel when needed.
- Collaboration and team work. Maintains the highest standards of ethical behaviour.
- Results and performance driven.
- Strong analytical ability and associated problem solving.
- Good time management and attention to detail.
- Knowledge and proficient in the use of Microsoft products including, Excel, Word and Powerpoint.