Sr. Specialist, Quality Assurance (Analytics) job in Billerica
|Employer:|| Sun Pharma|
|Job Type:||Full Time|
This position is based in Billerica, Massachusetts.
The Sr. QA Analytics Specialist 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 and compiles monthly Quality metrics for internal and corporate review and analyzes trends to implement corrective and preventive actions to mitigate adverse trends.
Area Of Responsibility
•Collaborates with multiple departments to ensure timely documentation, root cause analysis, and QA closure of Stage II OOS investigations and OOT investigations
•Works directly on technical investigations relating to product quality Complaints
•Provides verbal and written responses / resolutions to customers regarding product quality Complaints or product inquiries
•Participates in other quality investigations and risk assessments as requested to perform review of documents, processes, testing, etc.
•Plans and coordinates routine and non-routine projects requiring independent judgment, evaluation and selection of compliant scientific techniques
•Performs analysis of Annual Product Review (APR) statistics reported for each product, investigates any OOT testing results identified in the product APR, and provides written summary for inclusion in the APR
•Compiles and reports 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
•Drives projects to improve the QMS for compliance, efficiency, or corporate needs
•Authors / revises standard operating procedures (SOPs) and test methods, as required.
•Strong knowledge of instrumental and wet analytical chemistry
•Strong knowledge of microbiology testing
•Experience with the manufacture and testing of radiopharmaceuticals is strongly preferred
•Strong familiarity with regulatory / compliance environment (cGMP, GLP) associated with parenteral drug manufacture
•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
•Strong working knowledge of MS Office software Work Conditions:
•Office Physical Requirements:
•Sit, stand, walk, use hands and fingers to handle or feel, talk or hear, stoop, kneel, crouch or crawl
•Lift up to 10 lbs.
•Operates computer/office machines Travel Estimate
•Up to 5 % BS in chemistry or related scientific field Experience
•Minimum 6-8 years related experience in a pharmaceutical manufacturing environment
•Working knowledge of cGMPs, GLPs