- Prepare Annual Product Quality Review (APQR) report for each commercial product as per predefined timeline.
- Support and collaborate with multiple departments to ensure timely documentation, root cause analysis, and QA closure of Stage II OOS investigations and OOT investigations
- Work directly on technical investigations relating to Product Quality Complaints
- Participate in other quality investigations and risk assessments as requested to perform review of documents, processes, testing, etc.
- Implement electronic Quality Systems, such as eQMS, EDMS, and LMS, providing procedures and training for employees to effectively use the electronic Quality Systems
- B.S. in chemistry or related scientific field
- Minimum 6-8 years related experience in a pharmaceutical manufacturing environment.
- Working knowledge of cGMPs, GLPs
- Strong knowledge of Trackwise to handle electronic Quality Manage System (eQMS) data
- Strong familiarity with regulatory/compliance environment (cGMP, GLP) associated with parenteral drug manufacture.
- Base salary range of $110,000 to $118,000 based on experience and qualifications, as well as geographical market and business considerations.
- +10% bonus
- Paid time off and holidays
- 401K and company match
- Health insurance
- Relocation Assistance
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Quality Assurance Compliance Manager - Billerica, United States - Wimmer Solutions
Found in: Appcast US C2 - 6 days ago
Description
SENIOR ASSOCIATE, COMPLIANCE (PRODUCT QUALITY)
BILLERICA, MA (ONSITE)
At Wimmer Solutions, we believe care creates community. We work smart; we have built a reputation for results-oriented, innovative, business and technology solutions that help companies execute on their strategic initiatives. We have fun; we love our work. We are positive, kind, and hungry to learn. We give big; we aim to make a real impact on the causes that affect the communities we serve and build strong relationships with the dedicated volunteers and nonprofit organizations working to address them.
We are all about people and community. Since 2002, we have offered technology staffing and managed services for the greater Seattle area and throughout the United States. We focus on getting to know our clients and candidates to create lasting partnerships and ensure success.
Our client is looking for a Senior Associate, Compliance (Product Quality) who will provide scientific support in the root cause analysis and closure of OOS investigations, OOT investigations and product quality complaints; ensures compliance with Good Laboratory Practices (GLP), current Good Manufacturing Practices (cGMP) and Quality Management System standards, compiles monthly Quality metrics for internal and corporate review, and analyzes trends to implement corrective and preventive actions to mitigate adverse trends.
WHAT YOU GET TO DO
WHAT YOU BRING
Must be able to work for a US based company without requiring visa sponsorship.
COMPENSATION AND BENEFITS
MORE ABOUT WIMMER SOLUTIONS
Wimmer Solutions is proud to be an equal-opportunity employer. All applicants will be considered for employment regardless of race, color, religion or belief, age, gender identity, sexual orientation, national origin, parental status, veteran, or disability status. Wimmer Solutions is committed to achieving a diverse employee network through all aspects of the hiring process and we welcome all applicants.
If you are passionate about what you do and want to join a diverse team dedicated to diversity, equity, and inclusion in the workplace, we would love to hear from you. Get the job you have always wanted. You will join a broad team of professionals who are energized about their careers as well as their community. For more career opportunities or to refer a friend, please visit and talk to a recruiter today.
