Quality Specialist

Requisition ID: 24350

Grace, a Standard Industries company, is a leading global supplier of catalysts, engineered materials and fine chemicals. We provide innovative products, technologies and services which our customers use to manufacture everyday products like renewable fuels, pharmaceuticals, toothpaste, cosmetics, food packaging, beer, edible oils and more. Our thousands of employees help shape a better future at our global headquarters in Columbia, MD and locations worldwide.

Job Description

Grace is hiring a Quality Assurance Specialist to work at our Tyrone, PA manufacturing site. We produces a portfolio of products including specialty pharmaceutical, food grade nutraceuticals, performance chemicals, agricultural chemicals, and refinery catalysts.

As a Quality Specialist, you will report to the Quality Assurance Manager and be responsible for carrying out Manufacturing Quality Assurance functions within the plant. This includes resolution of deviations, performance of product impact analysis and corrective and preventive action for events, leading and participating in investigations, approval of standard operating procedures, quality improvement programs, risk management, and assurance of cGMP and compliance. You will be an integral member of the Quality Operations team and provide support to site leadership and customers.

Responsibilities

• Review and approve product / process investigations (deviations, OOS), change records, CAPA, and other quality systems documentation as necessary.
• Lead material review boards to determine product disposition to control nonconforming product and meet customers and plant on-time expectations.
• Develop and provide quality reports and review trending on assigned areas of responsibility.
• Work independently and with project teams to develop design control deliverables including quality plans, manufacturing & inspection documentation, test methods, and any other necessary documentation.
• Meet company and departmental goals in the continuous improvement of all products, services and processes.
• Support quality assurance improvement activities by evaluating products, processes, or materials to develop control or improvement strategies intended to enhance the customer experience.
• Lead and support root cause failure analysis and implementation of corrective and preventive actions to preclude reoccurrence.
• Lead facility driven quality projects/initiatives intended to meet defined objectives.
• Understand and apply applicable regulatory requirements and standards to the plant quality system
• Develops standard operating procedures; ensures procedures comply with policy and make sense.
• Performs batch release.
• Conducts audits and inspections: internal, customer, and regulatory.

Required Qualifications

• B.S. degree, preferably in Biology, Chemistry or Engineering discipline.
• 2-4 years’ experience in a regulated industry in capacity of Manufacturing, Quality, or Engineering.
• Knowledge of quality or compliance management such as regulations and standards affecting pharmaceutical manufacturing, including ISO 9001.
• Experience on projects across multiple functions and levels.
• Strong verbal and written communication skills.
• Effective problem solving and analytical skills.
• Strong interpersonal relations / communications skills.

Preferred Qualifications

• Knowledge of regulations- 21 CFR 210 /211, 117, 820, ICH Q7.
• ASQ certification (CQE or CQA).
• Experience with risk management tools and techniques.
• Lean Six Sigma training.
• Expertise in quality management tools.
• Auditing experience.

Benefits

• Medical, Dental, Vision Insurance
• Life Insurance and Disability
• Grace Wellness Program
• Flexible Workplace
• Retirement Plans
• 401(k) Company Match
• Paid Vacation and Holidays
• Parental Leave
• Tuition Reimbursement
• Company Donation Match Program

Other Compensation

Grace is not accepting unsolicited assistance from search firms for this employment opportunity. Please, no phone calls or emails. All resumes submitted by search firms to any employee at Grace via email, the Internet or in any form and/or method without a valid written search agreement in place for this position will be deemed the sole property of Grace. No fee will be paid in the event the candidate is hired by Grace as a result of the referral or through other means.

EOE Statement: W. R. Grace & Co. is committed to creating a diverse environment and is proud to be an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, gender, gender identity or expression, sexual orientation, national origin, genetics, disability, age, veteran status or any other legally protected status.

If you are a qualified individual with a disability or a disabled veteran, you may request a reasonable accommodation.