Senior Specialist, Quality Assurance

7 days ago

Milton, Ontario, Canada Innomar Strategies Inc. Full time
QA Release Specialist (12 Month Contract) page is loaded QA Release Specialist (12 Month Contract)

Apply locations Milton, ON time type Full time posted on Posted Yesterday job requisition id R242324 Our team members are at the heart of everything we do.

If you want to make a difference at the center of health, come join our innovative company and help us improve the lives of people and animals everywhere.

Perform timely review and assessment of documents received from clients/foreign sites, including but not limited to, manufacturing and packaging records, Certificates of Analysis, Certificates of Manufacture, and other product release documents.

Perform quality and regulatory reviews and oversight on imported products as assigned making quality decisions and addressing or resolving problems based on analysis and consultation with clients.

Coordinate with clients and/or foreign sites or other internal departments with launch activities, the compilation of complete GMP Quality documents to support the importation of client products.

Provide Quality Assurance guidance and support to potential new clients or new products as assigned.
~ Management of Customer complaints : receipt and triage of customer complaints, analyzes customer complaints and identifies trends and tendencies with respect to lot, product, and type of complaint and determines the cause; drafts complaint reports; Coordinate with clients and/or foreign sites for the receipt, review and updates to master documents to ensure compliance to GMPs and in relation to product release activities.
~ Maintain and review in-house and client-based quality documents such as APQR, stability reports, equipment and facility qualification/validation protocols and reports, product label, temperature study etc. Sustain an effective system for maintaining copies of documents received from clients/foreign sites as well as those submitted to Health Canada, allowing ease of location and retrieval of records.
~ Management and control of changes : supports the initiation of change requests for equipment, primary and secondary components, processes, systems and documentation; closes changes upon implementation. Support the QA department in ensuring Innomar GMP facilities operate and are in compliance with Good Manufacturing Practices and applicable Health Canada regulations at all times which may include review and approval of quality failures and non-compliance investigations; Provide support during audits/inspections by internal, client, third party or regulatory bodies.
~ Recall Management :

provide support to the Senior Manager, QA for Product Recalls, including customer notification, coordination of customer returns and maintaining documentation.

~ Assist the QPIC in ensuring that Innomar operates and is in compliance with the Narcotic Control Regulations as set out by Health Canada. Assist the QPIC to ensure that all transactions occurring at the respective distribution centre are in compliance with Innomar SOP's relevant to the Narcotic, Precursor, and GMPs, including but not limited to Shipping, Receiving, Returns, Pick & Pack, Inventory Control, Credits, Security/Maintenance, Government Reporting, Record Maintenance, Destruction and Government reporting. Assist the QPIC in providing the Senior Manager, QA with any reporting to Government, regarding narcotic discrepancies and other required reports.

Support Quality Organization:
Provide assistance to the QA Senior Manager Quality Assurance as required. Performs other projects as assigned
~ Bachelor of Science degree required
Minimum of 3-5 years' experience in GMP Quality Assurance/Quality Control/Compliance
Direct pharmaceutical Quality Assurance/Quality Control/Compliance experience
Regulatory Affairs or Quality Assurance Certification as asset

Drugs, Medical Devices, Natural Health Products, Narcotics, etc.) Efficient in compiling, managing and interpreting data from various sources (e.g.

from clients and their affiliates).
Knowledge of computers to effectively utilize common office applications (e.g., Outlook, PowerPoint, Word, Excel and Adobe Acrobat).

In addition to traditional offerings like medical, dental, and vision care, we also provide a comprehensive suite of benefits that focus on the physical, emotional, financial, and social aspects of wellness.

This encompasses support for working families, which may include backup dependent care, adoption assistance, infertility coverage, family building support, behavioral health solutions, paid parental leave, and paid caregiver leave.

To encourage your personal growth, we also offer a variety of training programs, professional development resources, and opportunities to participate in mentorship programs, employee resource groups, volunteer activities, and much more.


Full time Affiliated Companies:

Cencora is committed to providing equal employment opportunity without regard to race, color, religion, sex, sexual orientation, gender identity, genetic information, national origin, age, disability, veteran status or membership in any other class protected by federal, state or local law.

Therefore, harassment is prohibited and all matters related to recruiting, training, compensation, benefits, promotions and transfers comply with equal opportunity principles and are non-discriminatory.

AmerisourceBergen is committed to providing reasonable accommodations to individuals with disabilities during the employment process which are consistent with legal requirements.

Accessibility Policy
When requested, AmerisourceBergen will accommodate people with disabilities during the recruitment, assessment and hiring processes and during employment.

Cencora is a leading global pharmaceutical solutions company that is committed to improving the lives of people and animals everywhere.

We connect manufacturers, providers, and patients to ensure that anyone can get the therapies they need, where and when they need them.

We work together every day to help our partners bring their innovations to patients worldwide, creating unparalleled access and impact at the center of health.

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