Job Description
Role: QA Specialist Location: Cambridge, MA 02142 Duration: 1 YEAR Shift: 2nd shift- 3pm - 11pm Monday through Friday 100% ON SITE Description: We are seeking a highly skilled and experienced Senior QA Specialist to join our dynamic team. In this role, you will be responsible for overseeing the quality assurance process, ensuring that our products meet both Local and Global quality standards.
Responsibilities: - Execute all activities following quality and regulatory standards and procedures.
- Promote a quality mindset and quality excellence approach to all activities.
- Continue support of continuous improvement culture and industrial excellence methodologies.
- Support employees and respective departments in a manner which is clear in approach, communication, and action.
- Provide proactive communication to customers to ensure timely escalation and resolution of issues. Follow up on issues to ensure completion in a timely manner. Support cross functional communication in all manners.
- Support batch release of drug substance including compilation of documentation, as needed
- Perform review of the manufacturing batch records for completeness and compliance with cGMPs as per regulatory requirements and internal procedures.
- Provide on the floor support to Manufacturing
- Perform SAP transactions applicable to batch record review
- Working knowledge and/or ownership of the following quality systems: Change Control, CAPAs, Deviations, and Self inspection auditing, QA reporting and approval of GMP documentation.
- Support GMP compliance and inspection readiness within the organization. Assist in coordination of work for the QA Operations team to facilitate timely release of product lots.
- Perform review in Blue Mountain Ram for calibration, work order activities
Basic Qualifications: We are looking for professionals with these required skills to achieve our goals:
- HS Diploma or equivalent and 8+ years of experience in a cGMP environment, OR associate degree and 6+ years of experience in a cGMP environment, OR bachelor's degree and 4+ years of experience in a cGMP environment.
- Previous experience working with quality systems having oversight of cGMP production operations including some or all of the following: batch release, SAP, batch record review
Preferred Qualifications: If you have the following characteristics, it would be a plus: - Bachelor of Science or Bachelor of Arts degree in a scientific discipline.
- Demonstrated experience in regulatory inspection activities.
- Ability to work on multiple projects on a tight timeline.
- Ability to prioritize and the flexibility to adapt to changing priorities.
- Working knowledge of cGMPs and associated regulatory requirements for the manufacture, testing, and release of pharmaceutical/biopharmaceutical products for international markets.
- SAP knowledge
- Experience working successfully both independently and in a team environment.
- Strong verbal and written communication skills.
- Able to interact with peers, subordinate and senior personnel in multidisciplinary environment including engineering, facility operations, validation, production, and QC.
- Able to prioritize and decide appropriate course of actions.
- Root cause analysis experience preferred.
- Vaccines experience a plus.
Job Tags
Local area, Shift work, Afternoon shift, Monday to Friday,