Job Description: The
QA Compliance Associate provides support to the company Deviation, Corrective and Preventive Action (CAPA) program through a complete assessment of Root Cause Analysis (RCA) of Deviations and vendor complaints/issues. Assure product compliance and product safety. Ensure accurate and timely data entry and oversight of the company Quality Systems related to Deviation, CAPA and vendor complaint activities.
- Lead, facilitate, and conduct deviations, non-conformances investigations.
- Author/draft investigation reports with minimal guidance.
- Ensure timely completion of investigations with accuracy, consistency and compliance with applicable SOPs/Policies, Specifications and related guidelines/regulations.
- Interview Subject Matter Experts (SMEs) and involved employee(s) across multiple shifts to investigate reported problems and assess the quality impact.
- Conduct investigational meetings with required team member(s) and Verify Investigational findings against documented process per SOP.
- Coordinate immediate actions in conjunction with QA and department management upon identification of a non-conformance.
- Utilize problem solving techniques and appropriate tools to determine root cause and appropriate causal factors.
- Facilitate root cause analysis meetings with key stakeholders to identify solutions for quality improvements based on identified trends.
- Work with cross functional team member(s) to develop appropriate CAPA actions.
- Ensure investigations, corrections and CAPA are generated and approved in a timely manner.
- Act as liaison as it relates to specific investigations during client calls and audits.
- Support and/or coordinate data collection required for management reviews, KPI reports, client trend review meetings, and all other established regular quality reporting and review mechanisms.
- Communicate/Escalate to management any issues or delays identified during the investigation process.
- Provide investigation training as needed to the Quality Unit and other departments to ensure that investigations are handled consistently throughout the company.
- Speak to assigned deviations during regulatory and client audits.
- Act as the QAC Lead Associate when requested by the QAC SUPERVISOR (in the absence of the QAC Lead Associate)
Qualifications: - Associates Degree in Biology, Chemistry or related field required.
- Bachelor's Degree in a science field desired.
- Sologic Certificate
- Minimum of 5 years related experience required with an Associate's Degree.
- Minimum of 2 years related experience required with a Bachelor degree.
- Pharmaceutical and FDA Regulated Experience required.
- Experience with technical writing, investigations, CAPA system, building and manufacturing processes/systems, QA operations systems, and QC analysis is required.
- Direct or supporting aseptic manufacturing experience in bio/pharma industry desired.
- Microsoft Word & Excel required.
- Knowledge of cGMPs required.
- Basic exchange of information.
- Managing conflict and influencing outcomes.
- Must have demonstrated effective verbal and written communication with all levels of staff.
- Must have demonstrated strong interpersonal skills and conflict management.
- Must have ability to prioritize investigations based on impact to the facility and release of batches.
- Provides analysis, diagnosis or production tasks, which noticeably influence results.
- Take leadership or controlling role on end results desired.
Other Physical requirements:- Ability to lift 30 pounds unassisted.
- Prolonged sitting required
Location: Spokane, WA - On Site, Full-TimeCompensation & Benefits That Start on Day One - Because Your Well Being Matters Hiring Wage: $81,800 - $109,100 annually, with opportunities for growth, promotion, and annual raises.
At Jubilant HollisterStier, we don't believe in waiting periods. From the moment you join us, you and your family have access to a full suite of benefits designed to support your health, stability, and long-term success.
Starting on your first day, you receive:- Medical, Dental & Vision coverage
- Flexible Spending Accounts (FSA) & Health Savings Accounts (HSA)
- Life & AD&D Insurance
- Short-Term & Long-Term Disability Insurance
- Employee Assistance Program
Unlock Your PotentialIf you're seeking a dynamic and rewarding career, we welcome your application today. Apply online:
Careers - Jubilant HollisterStier
