- 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.
- Provide verbal and written responses/resolutions to customers regarding product quality Complaints or product inquiries.
- Participate in other quality investigations and risk assessments as requested to perform review of documents, processes, testing, etc.
- Plan and coordinate routine and non-routine projects requiring independent judgment, evaluation and selection of compliant scientific techniques.
- Perform statistical analysis of critical attributes and trending of QMS events for each commercial product and provide a scientific rationale for the outcome of the conclusion presented in the APQR.
- Author Annual Product Quality Review (APQR) report for each commercial product as per predefined timeline (hundreds of pages).
- Compile and report on Quality metrics at monthly Quality meetings, creating presentation materials to identify trends, quality and compliance risks, and make recommendations for changes to processes, procedures, and training, as applicable.
- Manage electronic Quality Management System (TrackWise).
- Implement electronic Quality Systems, such as eQMS, EDMS, and LMS, providing procedures and training for employees to effectively use the electronic Quality Systems.
- Develop presentation monthly for QRB meeting based on eQMS, Quality Matrix and Monthly Quality investigation Board (QIB) meeting.
- Follow up with stake holders for timely closures of all open QMS documents and update TW accordingly. Finally, present the status/findings to QRB meetings.
- Drive projects to improve the QMS for compliance through Trackwise (TW), efficiency, or corporate needs.
- Author/revise standard operating procedures (SOPs) and test methods as needed.
- BS 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 or Veeva to handle electronic Quality Manage System (eQMS) data.
- Strong knowledge of instrumental and wet analytical chemistry and microbiology testing.
- Strong working knowledge of MS Office software.
- Strong familiarity with regulatory / compliance environment (cGMP, GLP) associated with parenteral drug manufacture.
- Experience with the manufacture and testing of radiopharmaceuticals is strongly preferred.
- Prefer knowledge in handling SAP, EDMS, LMS, Mast Control, etc.
- 5 weeks PTO annually
- Great health coverage/plans
- 401k matching
- Corporate Discounts
- Tuition reimbursement
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Sr Product Quality Associate - Billerica, United States - Software Guidance and Assistance, Inc.
Description
Software Guidance & Assistance, Inc., (SGA), is searching for a Senior Product Quality Associate (Pharmaceutical Mfg Compliance) for a Direct Placement assignment with one of our premier Pharmaceutical clients in Billerica, MA.
Onsite work 5 days per week required - fully in office
This is a full-time opportunity
Relocation candidates are welcomed (generous relo package offered)
Visa candidates are welcome to apply
Responsibilities:
Provides 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. 1000's of products.
SGA is an Equal Opportunity Employer and does not discriminate on the basis of Race, Color, Sex, Sexual Orientation, Gender Identity, Religion, National Origin, Disability, Veteran Status, Age, Marital Status, Pregnancy, Genetic Information, or Other Legally Protected Status. We are committed to providing access, equal opportunity, and reasonable accommodation for individuals with disabilities in employment, and our services, programs, and activities. Please visit our company EEO page to request an accommodation or assistance regarding our policy.
