Qc Analyst

2 weeks ago


Windsor, Canada Pancap Pharma Full time

Pancap Pharma Inc. is a leader in specialty contract manufacturing of pharmaceutical dosage forms. The company began its contract manufacturing operations in January of 1994 and since then has translated experience into quality production for a wide range of clients.

From concept to full package delivery, we have the experience and commitment to meet the needs of even the most unique clients. We offer a wide range of manufacturing and support capabilities including capsule fabrication, compounding of non-sterile liquids, packaging, labelling, regulatory affairs, testing and quality assurance. The products we manufacture are then shipped around the world. Quality is the cornerstone upon which Pancap has built its foundation. Our Quality Assurance System was developed in order to ensure the production of safe and effective products in compliance with the current Good Manufacturing Practice (cGMP) regulations, industry standards and our client's specifications/marketing requirements.

We are growing our operations with a brand-new state of the art facility in **Windsor, Ontario** and we are looking for a Quality Assurance Associate.

**ROLE AND KEY REPSONSIBILITIES**
- Always respects and adheres to company policies
- Perform all work in accordance with cGMP and approved procedures to ensure the technical integrity and regulatory compliance of all data generated
- Check results for accuracy and ensure compliance to cGMP/GLP and SOP’s
- Good understanding of test procedures and basic analytical principals
- Able to operate laboratory instrumentation such as: Karl Fisher, UV/IR Spectrophotometers, Dissolution apparatus, Viscometer, Polarimeter, TOC, GC, pH Meter, Conductivity meter, &718 STAT Titrino
- Identifies simple technical problems related to instruments operation and solves as necessary
- Identifies preventable errors prior to the start or completion of the test and report as appropriate
- Applies the knowledge gained previously in the lab to improve the quantity and quality of work
- Organizes work efficiently and utilizes time efficiently
- Able to multitask and follow lab schedule as written
- Completes documentation as soon as testing is done and review data for completion and accuracy prior to handing in for review by supervisor or designate
- Recognize and report OOS/OOT results to Supervisor in a timely manner (upon completion of testing)
- Issue an OVR/MVR/OOS or change Request as needed
- Perform validation of test methods and production processes
- Takes responsibility and accountability for the duties assigned
- Able to work independently and within a team environment. Actively participate in team related tasks. Support the team on meeting deadlines
- Participate in on-going training as required and complete training in specified time frame
- Ability to work shift work or longer hours when required
- Communicates to Supervisor or designate any potential delay for the projects assigned in a timely manner
- Sample and test all Raw Materials according to current SOP’s / Methods and within GMP compliance
- Monitoring of Airflow patterns and pressures in Production Areas
- Calibration of Test Equipment
- Environmental Microbial Sampling
- Testing and results evaluation of Stability Product
- Sampling and Testing of Packaging components
- Monitoring temperatures throughout the Plant
- Weekly water testing utilizing TOC and Conductivity meter
- Adhere to Health and Safety Policy
- Perform other duties as assigned

**QUALIFICATIONS AND EXPERIENCE**
- University Degree or College Diploma in a science related field
- Minimum of 2 years Quality Control experience preferably in a pharmaceutical laboratory environment.
- Good knowledge of laboratory GMP and demonstrated proficiency in analytical techniques
- Works well in a fast-paced environment both individually and as part of a team.

**Job Types**: Full-time, Permanent

**Benefits**:

- Extended health care

Schedule:

- 8 hour shift
- Monday to Friday

Supplemental pay types:

- Overtime pay

Work Location: In person


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