Senior Associate, Compliance Specialist
4 days ago
Job Summary
The Senior Associate, Compliance Specialist provides scientific support in the root cause analysis and closure of Out-of-Specification (OOS) investigations, Out-of-Trend (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.
Key Responsibilities
- Support and collaborate with multiple departments to ensure timely documentation, root cause analysis, and Quality Assurance (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 Quality Management System (QMS) events for each commercial product and provide a scientific rationale for the outcome of the conclusion presented in the Annual Product Quality Review (APQR)
- Prepare APQR report for each commercial product as per predefined timeline
- 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, Electronic Document Management System (EDMS), and Learning Management System (LMS), providing procedures and training for employees to effectively use the electronic Quality Systems
- Develop presentation monthly for Quality Review Board (QRB) meeting based on eQMS, Quality Matrix, and Monthly Quality Investigation Board (QIB) meeting
- Follow up with stakeholders for timely closures of all open QMS documents and update TrackWise 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 required
- Other duties as assigned
Work Environment
- Office
Physical Requirements
- Stand, walk, sit, use hands and fingers to handle or feel, reach with hands and arms, stoop, kneel, crouch or crawl, climb or balance
- Talk or hear
- Close vision
- Computer/office machines
- Lift up to 10 lbs.
Some travel outside of company facility required
Travel Estimate
- Up to 5%
Education and Job Qualifications
- Bachelor's degree in chemistry or related scientific field
- Superior internal and external customer service/people skills
- Ability to manage multiple responsibilities and projects in a fast-paced environment, while performing in an efficient manner
Experience
- Minimum 6-8 years related experience in a pharmaceutical manufacturing environment
- Working knowledge of cGMPs, GLPs
- Strong knowledge of TrackWise to handle electronic Quality Management System (eQMS) data
- Strong knowledge of instrumental and wet analytical chemistry
- Strong knowledge of microbiology testing
- Strong working knowledge of MS Office software
- Preferably knowledge to handle SAP, EDMS, LMS, Master Control, etc...
- Experience with the manufacture and testing of radiopharmaceuticals is strongly preferred
- Strong familiarity with regulatory/compliance environment (cGMP, GLP) associated with parenteral drug manufacture
Compensation and Benefits
- The presently-anticipated base compensation pay range for this position is $98,000 to $119,500. Actual base compensation may vary based on a number of factors, including but not limited to geographical location and experience. In addition, this position is part of the Annual Performance Bonus Plan. Employees are eligible to participate in Company employee benefit programs which include medical, dental, and vision coverage; life insurance; disability insurance; 401(k) savings plan; flexible spending accounts; and the employee assistance program. Employees also receive various paid time off benefits, including vacation time and sick time.
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