Sr. Specialist, Quality Assurance AuditorApply Now
Location: Norwood, Massachusetts 02139
Employment Type: Direct Hire
Seeking a Senior Quality Assurance Auditor. The individual in this role will be responsible for providing Quality Assurance (QA) support for the Supplier Quality program.
- Primarily work with Supply Chain and vendors to ensure a robust supply of GMP materials are available to support the clinical manufacturing programs.
- Support supplier quality systems and governance, initiate audit plans, audit vendors, and drive continuous GMP improvement in the supply chain.
- Works on assignments requiring considerable judgement and initiative.
- Understands implications of work and makes recommendations for solutions.
- Create and maintain data tracking systems that govern the supplier quality program.
- Must have experience in a biotech or pharmaceutical cGMP environment.
- Responsible for auditing suppliers and will be accountable for monitoring supplier performance.
Here’s What We’ll Bring to the Table:
- Daily on-site catered lunches.
- Company-provided iPhone.
- Free parking, monthly subway pass or a subsidized commuter rail pass.
- 90% paid healthcare coverage. Including: medical offered through BCBS (HMO/PPO), dental, and vision offered through VSP.
- Flexible Spending Accounts for medical expenses and dependent care expenses.
- 401k (traditional and Roth offered) with 50% match on first 6% deferred. Match is vested immediately.
- Paid insurance coverage, including: life insurance, short-term and long-term disability
- Voluntary legal assistance plan
- 15 days’ vacation and 7 sick days per year, in addition to a discretionary winter shut down and 11 company paid holidays.
- Adoption assistance, competitive parental leave, discount to local childcare centers, as well as access to Care.com
Here’s What You’ll Bring to the Table:
- BS in a scientific or engineering discipline
- 5-8 + years’ experience in pharmaceutical / biotech industry within Quality Assurance executing audits; MS preferred with 2-5 years’ experience
- Outstanding communication skills (verbal and written)
- Ability to manage multiple projects in a fast-paced environment
- Ability to effectively collaborate effectively in a dynamic, cross-functional matrix environment.
- Has advanced understanding of the job and applies knowledge and skills to complete a wide range of tasks. Familiar with a variety of the field's concepts, practices, and procedures. Requires thorough knowledge of the department and company operations, policies and procedures.
- High degree of independence. Requires very limited supervision when acting or making decisions within existing policies and practices. Relies on experience and judgment to plan and accomplish goals.
Here’s What You’ll Do:
- Execute supplier audits
- Partner with supplier to establish relationships
- Aide in the establishment and maintenance of policies and procedures for the supplier management program
- Develop Audit Plans
- Monitor supplier metrics to ensure supplier performance is measurable
- Maintain supplier data
- Track supplier conformance to audit commitments and corrective actions (SCAR’s)
- Review supplier change notifications and determine impact to internal systems
- 60% Travel(combo of domestic and some international)
Yhoumey is a recruiter for our direct hire team. She enjoys partnering with candidates to find the right career placements.
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