Baxter Life Science QA Associate Job – Apply Online
Assoc. Mgr, Quality Assurance
At Baxter, we are deeply connected by our mission. No matter your role at Baxter, your work makes a positive impact on people around the world. You’ll feel a sense of purpose throughout the organization, as we know our work improves outcomes for millions of patients.
Baxter’s products and therapies are found in almost every hospital worldwide, in clinics and in the home. For over 85 years, we have pioneered significant medical innovations that transform healthcare.
Together, we create a place where we are happy, successful and inspire each other. This is where you can do your best work.
Join us at the intersection of saving and sustaining lives—where your purpose accelerates our mission.
Job Description/Position Summary
The Quality Assurance, Mgr. will be responsible for compliance oversight with studies and supporting suppliers (i.e., Phase 1 Units, Labs, CROs, Research Sites, etc.) within the Pharma Segment. The oversight will include vendor qualifications, audits, CRO and site oversight and site monitors assigned to studies.
Audit Responsibilities
- Proactively anticipate the horizon of regulations and make sure that current GCP/Clinical Trial practices reflect current and future industry practice.
- Independently performs Clinical site audits, vendor (such as central labs, bioanalytical labs, clinical trial supplies packaging and retention facilities etc.) audits and internal audits as required ensuring adherence to audit schedules.
- Determine if there is a site compliance issue and take appropriate action (i.e., for cause audit, co-monitor trip, etc.).
- Serves as interface for inspections and audits relating to GCP compliance.
- Open and manage Supplier Corrective Action Report (SCAR) as needed.
- Open and manage Non-Conformance (NCR) as needed.
Monitoring Oversight Responsibilities
- Oversee assigned site monitors to the study and ensure the following activities are being done as expected (i.e., complete, thorough, escalation as needed):
- Monitors activities conducted by clinical investigative sites as they relate to sponsor clinical studies to ensure successful execution of the protocol.
- Oversee the vendor monitoring activities as needed.
- Ensure adherence to federal regulations and applicable local regulations, Good Clinical Practices (GCPs), ICH Guidelines, Standard Operating Procedures (SOPs), Protocol/Amendment(s), Monitoring Plans, and to quality standards in conducting clinical research.
- Ensure subject safety and verify diligence in protecting the confidentiality and well-being of study subjects.
- Conducts site qualification, site initiation, interim monitoring and close out visits for Phase 1-4 studies or accompanies the CRO site monitor when performing these visits.
- Performs source data verification as defined in the monitoring plan (including ICF review).
- Verify completeness, accuracy, consistency, and compliance/quality of trial data collected at study sites; identify deficiencies and discrepancies and provide remedial training and/or corrective action as required; generate and resolve queries in between monitoring visits.
- Complete monitoring reports and follow-up letters, which includes providing summaries of significant findings, deviations, deficiencies, and recommended action to secure compliance.
- Responsible for timely identification, escalation, and resolution of problems or issues that could affect the results or timely completion of the trial, or any protocol deviations, and for suggesting mechanisms for solving the problem.
- Involved in the review of study plans.
- Checks Investigator site file for completeness.
- IP management and accountability.
- Manages Key Performance Indicators assigned to monitoring activities as defined by the study team.
Qualifications
Education and Experience (in years):
- BA or BS with scientific discipline (Pharmacy, Nursing, Clinical Sciences, Health/Life Sciences, Molecular Biology, Biochemistry and/or Human Physiology), B Pharm or RN or BSc Nursing degree or equivalent. Minimum of 5 years of clinical research monitoring experience and auditing.
- Industry certification – SOCRA or ACRP, or equivalent preferred.
- Read, write, and speak fluent English.
Knowledge and skills:
- There will be expectations of being in closet Baxter office when work requires interactions with Pharma team members and may be required to be on-site with CRO’s during the time studies are being executed.
- Ability to travel preferred but flexible, maximum 40%.
- Current in-depth knowledge of regulations governing clinical research, ICH/GCP Guidelines, and applicable federal regulations.
- Experience in monitoring/auditing sites, ability to prioritize and multi-task in a fast-paced environment.
- Detailed oriented, with strong time management and organizational skills.
- Excellent communication and team skills.
- Effective interpersonal skills.
- Working knowledge and understanding of appropriate therapeutic indications as they relate to the conduct of clinical trials.
- Proficient in Microsoft Office Applications, such as Word, Excel, Access, PowerPoint etc.
- Demonstrated business ethics and integrity.
Keywords: Baxter Life Science QA Associate Job, Quality Assurance Manager, Compliance Oversight, Clinical Site Audits, Vendor Audits, Monitoring Oversight, Site Qualification, Data Verification, Protocol Deviations, Clinical Trials. Baxter Life Science QA Associate Job – Apply Online. Please ensure you are subscribed to the Biotecnika Times Newsletter and our YouTube channel to be notified of the latest industry news. Follow us on social media like Twitter, Telegram, Facebook
