Sample Coordinator/qpic

3 weeks ago

Mississauga, Canada Contract Pharmaceuticals Full time

Contract Pharmaceuticals Limited is a contract manufacturer and packager of prescription and over the counter pharmaceutical products. We are dedicated to providing comprehensive and innovative outsourcing services that exceed the uncompromising demands of the global pharmaceutical industry.

The Sample Coordinator oversees receipt, control and lifecycle management of raw material, bulk and finished product samples in the QC Laboratory, ensuring that these activities are carried out in compliance with regulatory and Canadian Controlled Drug Substances Act (CDSA). Designated as Qualified Person in Charge (QPIC)/Alternate Qualified Person in Charge (AQPIC) for laboratory samples.

**SPECIFIC RESPONSIBILITIES**:

- Ensures samples are received in a timely manner, accurately identified, labeled, stored as indicated by required storage conditions, logged, tracked and reconciled to maintain sample integrity, accurate inventory records and clear chain of custody from receipt through disposal.
- Identifies discrepancies (if any) between samples and related documentation received and facilitates timely resolution of issues prior to samples are made available for analysis. Verifies that sample information including methodology and method version is correct, current and specification corresponds to the QA approved master specs.
- Logs samples (LIMS or manually, as required), prepares required documentation, allocates samples and documentation for analytical / microbiological testing. Logs/labels reagents and maintains and corresponding MSDS.
- Coordinates testing with external laboratories when applicable, sends samples, follows up on results and provides results to the appropriate Department to meet QC target release timelines.
- Responsible for working in compliance with established safe work practices and procedures; properly uses personal protection and safety equipment as required by CPL; reports any injury or illness immediately and notifies CPL of any hazards, unsafe acts or conditions in the workplace.- Ensures that the required physical and procedural security requirements are established, maintained and checked regularly. Reports any proposed security changes to the OCS and ensures approval is obtained prior to implementation.
- Monitors and controls the storage, access and chain-of-custody of all controlled substances and precursors at the facility. Ensures that procedures are in effect for the safe and secure receipt, handling, movement and disposal of precursors and controlled substances within the facility.
- Facilitates the receipt and shipment of precursors and controlled substances by coordinating the required permits and chain-of-custody records.
- Performs monthly physical inventories and maintains the appropriate records.
- Hosts audits related to Controlled Substances. Participates in and supports Lean initiative and Continuous Improvement projects in the QC Laboratory.
- Other duties as assigned.

**QUALIFICATIONS**:

- Bachelor of Science Degree in a chemistry or related field, combined with minimum 2-3 years of pharmaceutical industry experience in a GMP setting.
- Must have knowledge of, and fulfill all Health Canada requirements for QPIC or AQPIC and RPIC designations:

- recognized university degree in biology, chemistry, biochemistry, pharmacology, pharmacy, microbiology, chemical engineering, medicine, dentistry or veterinary medicine.
- courses in pharmacology are required in the absence of a pharmacology/pharmacy degree.
- Knowledge of Health Canada and U.S. FDA GMP requirements for pharmaceutical testing, the Controlled Drugs and Substances Regulations and the Precursor Control Regulations.
- High attention to detail in creating and maintaining records.
- Strong written and verbal English communications skills.
- Good working knowledge of LIMS, and Microsoft Office programs, especially Excel and Word.

**PHYSICAL DEMANDS AND WORKING CONDITIONS**:

- Some office work with computers in a laboratory setting and work conditions. Lab presence requires use of protective equipment, such as safety glasses, lab coat and appropriate footwear, to reduce personal exposure and injury.
- Receiving, inventorying, labeling and disposing of samples requires some reaching/bending and light lifting on a daily basis.
- Flexibility in hours of work to address emergency issues / controlled substance related activities outside of normal workday.We thank all applicants for their expression of interest; however only those selected for an interview will be contacted. No phone calls or agencies please.

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