Current jobs related to Quality Assurance Associate - Baulkham Hills - CellCarta
-
Quality Assurance Manager
11 hours ago
Surry Hills, Australia TMX Full time**Quality Assurance Manager** - 3-month contract with the view to extend - Based Sydney or Melbourne - Develop and deliver Quality Assurance program - Exciting opportunity with a global organisation TMX is Asia-Pacific’s leading business transformation consultancy with over 190 employees with offices in Australia, New Zealand and Asia and continued growth...
-
Baulkham Hills, New South Wales, Australia MSA - The Safety Company Full time $104,000 - $130,878 per yearOverviewAre you someone who is passionate, motivated, and driven to make a difference? If so, MSA Safety is the perfect fit for your career.At MSA, SAFETY is who we are AND it is what we do. We are a purpose-driven company committed to deploying innovation and technology to deliver on our Mission to help protect people and assets all around the world. We...
-
Compliance & Quality Assurance Manager
1 week ago
Para Hills, Australia Always Care Services Full time**Always Care Services Pty Ltd** is a privately owned company and operates as a Registered NDIS provider located in South Australia serving all Adelaide metro since 2016. We are a culturally sensitive, inclusive, and welcoming community where people with disabilities and those who are ageing, and their families are assisted in maintaining their independent...
-
Baulkham Hills, Australia MSA, The Safety Company Full time9252 - Operations (MissionOPS) - Full Time - Onsite - Baulkham Hills, Australia Overview Are you someone who is passionate, motivated, and driven to make a difference? If so, MSA Safety is the perfect fit for your career. - At MSA, SAFETY is who we are AND it is what we do. We are a purpose-driven company committed to deploying innovation and technology to...
-
Baulkham Hills, New South Wales, Australia MSA Safety Full time $104,000 - $130,878 per year9252Operations (MissionOPS)Full TimeOnsiteBaulkham Hills, AustraliaJob DescriptionOverviewAre you someone who is passionate, motivated, and driven to make a difference? If so, MSA Safety is the perfect fit for your career.At MSA, SAFETY is who we are AND it is what we do. We are a purpose-driven company committed to deploying innovation and technology to...
-
Quality Assurance Coordinator
2 weeks ago
Seven Hills, Australia solutionspersonnel Full time**Quality Assurance Coordinator - Bathroom Fittings Manufacturer** **Location**: Seven Hills **Employment Type**: Full-Time | **Immediate Start** Are you passionate about quality and detail? A leading **bathroom fittings manufacturer** is looking for a dedicated **Quality Assurance Coordinator** to ensure our products meet the highest industry standards....
-
Quality Assurance Coordinator
7 days ago
Seven Hills, Australia solutionspersonnel Full time**Location**: Seven Hills **Employment Type**: Full-Time | **Immediate Start** Are you passionate about quality and detail? A leading **bathroom fittings manufacturer** is looking for a dedicated **Quality Assurance Coordinator** to ensure our products meet the highest industry standards. Join a growing team committed to excellence in design and...
-
Orchard Hills, Australia N&A Operations Full timeN&A Group is a vertically integrated grower-led supplier of fresh produce. N&A has a rich and proud history spanning over generations. We are very proud of our tradition, culture, success and longevity. Over the past 60-years our business has evolved to meet and anticipate the changing needs of our customers. This is why we grow, we pack, we distribute and...
-
Aps 5 - Contract Assurance Officer
4 days ago
Orchard Hills, Australia Australian Government Full time$83,706 - $89,659 (plus Super) - Orchard Hills - NSW **The Role** As a Contract Assurance Officer, you will play a key role in the successful ongoing management and performance of the Explosive Ordnance Services Contract (EOSC). Duties include but are not limited to: - Assisting with the management of the Contract Assurance Framework, including the...
-
Aps 6 - Contract Assurance Manager
1 week ago
Orchard Hills, Australia Australian Government Full time$91,702 - $104,753 (plus Super) - Orchard Hills - NSW **The Role** As a Contract Assurance Manager, you will play a key role in the successful ongoing management and performance of the Explosive Ordnance Services Contract (EOSC). The Explosive Ordnance Service Contract is a performance based service delivery contract responsible for the storage,...
Quality Assurance Associate
3 weeks ago
**Quality Assurance**
**Summary**
The QA Associate is responsible for conducting and reporting quality assurance audits as scheduled. The QA Associate supports the QA department in assessing compliance of clinical studies with the applicable regulations, guidelines, study protocols, study workplans and internal SOPs and policies.
**Responsibilities**
- Performs audits of facility and studies for compliance with Good Clinical Practices (GCP), Good Clinical Laboratory practices (GCLP) Standard Operating Procedures (SOPs), clinical protocols, applicable regulatory documents, and guidelines (FDA, EMA, CAP/CLIA, ISO, Health Canada etc.)
- Reviews SOPs, Deviations/event Investigations, CAPAs, change control documents to ensure compliance.
- Audits study workplans, performs in-life process audits, study data audits and study reports.
- Conducts facility audits including equipment maintenance, training records, computer software validations (CSV),as applicable
- Performs supplier qualifications as applicable
- Keeps management informed of all findings and follows up on corrective action implementation.
- Assists in the writing or revision of QA SOPs, as applicable.
- Reviews QMS SOPs to ensure SOP contents are clear and consistent.
- Assists QA Management in hosting sponsor audits and regulatory inspections.
- Assist QA Management in generating metrics for quality management reviews.
- Assists QA department in the training of personnel on SOPs and GxPs as applicable
- Coordinate and interact with other department to ensure corporate, departmental and study goals are met.
- Coordinate and interact with other department to ensure corporate, departmental and study goals are met.
**Education**
- University degree in a scientific area, or equivalent.
**Main Requirements**
- 1-2 years QC/QA experience, preferable in a pharmaceutical/regulated environment.
- Experienced writing and reviewing SOPs.
- Clear and concise written and verbal communication in English
- Knowledgeable on Drug Development, Validation of Analytical methods, Quality Assurance and Regulatory Compliance.
- Experienced in various experimental techniques an asset including Immunoassays, Mass spectrometry etc.
- Knowledge of US FDA, EMA and Health Canada requirements on the conduct of clinical studies as they pertain to the activities of CellCarta.
- Detail Orientated, excellent investigation and troubleshooting skills.
- Strong Commitment, self-motivated
- Excellent Organization Skills
- Proven Flexibility to adjust to shifts in priorities, multitask while maintaining levels of quality.
- Ability to work well in a team environment.
- Ability to identify and/or resolve quality issues in a proactive, diplomatic, flexible, and constructive manner.
- Ability to design and implement quality processes and continuous improvement initiatives.
**Working Conditions**
- Actual job location is in Baulkham Hills, NSW 2153.
**Benefits**
We offer a wide range of benefits including:
- Competitive Compensation Package;
- Employee Annual Incentive Plan (EAIP);
- Professional, Dynamic, and Stimulating Work Environment.
**About CellCarta**
CellCarta is a leading provider of specialized precision medicine laboratory services to the biopharmaceutical industry. Leveraging its integrated analytical platforms in immunology, histopathology, proteomics, and genomics, as well as related specimen collection and logistics services, CellCarta supports the entire drug development cycle, from discovery to late-stage clinical trials. The Company operates globally with facilities located in Canada, USA, Belgium, Australia, and China.
Joining CellCarta means working with dedicated professionals who are focused on achieving our mission of impacting the future of patient therapy. We make a difference in the lives of patients around the world
**Join us as we make an impact on patient therapy**
v7zyu5CGLT
