Senior Quality Assurance Compliance Specialist – Beacon Hill Pharma – Cambridge, MA, USA
We are seeking an individual to fulfill a role in the GMP External Operations Quality Assurance group . In this role, the employee will be responsible for packaging batch record review and support of product distribution. It includes review of master batch records, evaluation of deviations and temperature excursions, and creation or revision of supporting SOPs.
- Executed batch record review for clinical and commercial packaging & labeling
- Review of shipping temperature data
- Cold Chain shipper qualification review
- Create and edit quality agreements
- Write and revise program SOP’s and associated Master Batch Records as required
- Write, review, and manage related Quality Systems
- Participate in external audits (CMO’s, packaging & labeling facilities)
- Train and support other staff and consultants
- Serve as a QA representative on teams as needed
- Assist with additional projects as needed
- BS degree or higher (preferably in Biology, Chemistry, or similar)
- Minimum 5+ years QA GMP experience in the pharmaceutical/biotechnology industry
- Direct QA experience with commercial DP packaging & labeling operations
- Previous experience with writing Technical Quality Agreements
- Experience in interactions with Contract Manufacturing Organizations a plus
- Previous GMP auditing experience is a plus
- Demonstrated ability to work in a team environment and manage projects independently
- Excellent written and oral communication skills
- Familiarity with FDA, EMA and ICH quality regulations
- Proficient in MS Office applications
- Ability to demonstrate high personal work standards and a sense of urgency about results; do everything possible to meet goals and deadlines; persist in the face of repeated challenges; accept responsibility for the outcomes of his/her own work
- Ability to be open to creative ideas suggested to solve problems and improve work methods; apply novel approaches to situations; collaborate with team members to brainstorm creative approaches; rethink situations to create new opportunities or overcome obstacles.
- Ability to establish personal standards of quality from own work processes, products and/or services; identify and apply “best practices” in own work; improve the efficiency of own works by eliminating barriers and streamlining work processes; measure and track own performance.
- Ability to earn trust and credibility by completing own share of the team’s work; place team priorities above own personal agenda; appropriately consider other’s opinions on matters that affect the team. Challenge proposed actions in a way that facilitates constructive discussion; support team decisions, even if different from own opinion.
MUST HAVE clinical packaging and labeling experience.