FSP QA Auditor II

About the role

Within our Analytical Services team, we have a functional service provider solution, which is a unique partnership that allows our customers to leverage the experience of our staff, while allowing you, the employee, to gain direct experience working onsite at a pharmaceutical/biopharmaceutical company, all while maintaining full-time benefits.

Responsibilities

• Supports the Quality Function that they are responsible for within GMP Operations
• Review and releasing of raw materials and supporting raw material testing
• Ensure that all products, processes, or system related quality activities related to raw material inspection and suppliers are in compliance with Corporate and governmental regulations
• Responsible for various aspects of quality assurance related to their functional area
• Provide support for raw material testing
• Evaluate quality, production and support areas for compliance to GMPs, BOPs, etc.
• Identify and investigate problems and help to resolve them
• Support troubleshooting and resolutions of quality compliance issues
• Assist with drafting raw material specification documents

Education and experience

• Bachelor's Degree in scientific field, or equivalent with related experience
• Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 2-4 years)
• In some cases, an equivalency, consisting of a combination of appropriate education, training and/or directly related experience, will be considered sufficient for an individual to meet the requirements of the role

Required qualifications

• Minimum of 2 years' experience in a cGMP-related field (Manufacturing, QA, QC, R&D in pharmaceutical or biologics industry)
• Knowledge of regulations and standards for pharmaceuticals (e.g. CFR, MCA, DEA)
• Some knowledge of plant and company level procedures

Preferred qualifications

• Quality Assurance/Regulatory Affairs/Compliance experience
• Incoming QA - receipt, review, release of raw materials into manufacturing operations
• Experience revising raw material specifications
• Supplier QA - experience in management of an Approved Supplier List, including supplier change notifications, audit assessments, and supplier records
• Previous knowledge of Viva/OneTrack is a plus

Working environment

• Able to communicate, receive, and understand information and ideas with diverse groups of people in a comprehensible and reasonable manner
• Able to work upright and stationary and/or standing for typical working hours
• Able to lift and move objects up to 25 pounds
• Able to work in non-traditional work environments
• Able to use and learn standard office equipment and technology with proficiency
• May have exposure to potentially hazardous elements, including infectious agents, typically found in healthcare or laboratory environments
• Able to perform successfully under pressure while prioritizing and handling multiple projects or activities

Pay

The salary range estimated for this position based in Massachusetts is $25.60–$38.00. This position may also be eligible to receive a variable annual bonus based on company, team, and/or individual performance results in accordance with company policy.

Benefits

• A choice of national medical and dental plans, and a national vision plan, including health incentive programs
• Employee assistance and family support programs, including commuter benefits and tuition reimbursement
• At least 120 hours paid time off (PTO), 10 paid holidays annually, paid parental leave (3 weeks for bonding and 8 weeks for caregiver leave), accident and life insurance, and short- and long-term disability in accordance with company policy
• Retirement and savings programs, such as our competitive 401(k) U.S. retirement savings plan
• Employees' Stock Purchase Plan (ESPP) offers eligible colleagues the opportunity to purchase company stock at a discount