QC Stability Associate - Pharma
Location
North York, ON | Canada
Job description
Job Information
Work Experience
Intermediate (5 to 8 years)
Industry
Pharma
City
North York
State/Province
Ontario
Zip/Postal Code
L4B
Job Description
Resolute Workforce Solutions (Staff augmentation subsidiary of Brevitas Consulting Inc.) is dedicated to helping organizations achieve tangible results and lasting improvements via successful project delivery, continuous process improvement, and effective management of change. Our expertise is in Commissioning & Qualification, Validation, Quality Systems, Regulatory Affairs, Engineering, and Project Management.
We are looking for a highly motivated and energetic professional to join our team as a
QC Stability Associate - Pharma in
North York, ON.
On-site position.
Responsibilities:
- Ensure stability studies are executed efficiently and in a compliant manner.
- Coordinate and execute compliant stability studies by preparing appropriate documentation, setting up and initiating stability studies within the LIMS system.
- Handle stability samples and maintaining inventory, tracking the stability schedule to monitor pull dates, and performing samples.
- Execute changes to stability protocols to ensure change controls are implemented on time.
- Support the timely submission of product license applications, license renewals, license amendments, and response to questions, in conjunction with Quality Operations and Regulatory Affairs, through the development and execution of stability studies and data analysis/interpretation.
- Assist regulatory inspections, audits, and ensure responses and actions are completed by the designated target date.
- Support the investigations and closure of quality incidents/deviations, as well as the completion of Corrective and Preventative Actions (CAPAs).
- Ensure training is updated to perform the designated cGMP and compliance with Health and Safety requirements.
Qualifications:
- Bachelor of Science Degree, with specialization in Biology, Biochemistry, Microbiology, Immunology, Chemistry, or related subject.
- 1-3 years pharmaceutical experience, preferably with Quality Control and/or Stability Studies.
- Proficient in use of MS Office, including Excel, Outlook, PowerPoint, and Word.
- Technical/Report writing skills.
- Attention to detail, ability to work independently and in collaboration with others, organization, time management.
To Apply:
- Click the “I’m interested” button below, or
- E-mail your resume in MSWord or pdf format to [email protected] with the following details in the e-mail's Subject Line: QC Stability Associate- Pharma: FIRST NAME, LAST NAME.
We thank all applicants in advance; however, we will only contact the candidates whose qualifications match closely to the job requirements.
We welcome and encourage applications from people with disabilities. Accommodations are available on request for candidates taking part in all aspects of the selection process.
Review our
Candidate Privacy Policy for more information.
Job tags
Salary