Sr Quality Systems Specialist

Description

• The Sr Specialist Quality Systems is responsible for providing quality assurance support for some or all of the following manufacturing processes: pharmaceutical products, medical devices, combination products and biologics.
• Specific areas of support may include the Document Center, Device QA, Labeling, Validation, Training and CAPA.
• This position will ensure that all product, process or system related quality activities from raw material inspection through shipment of final product are in compliance with Corporate and governmental regulations.
• This role is part of the External Quality Assurance (EQA) team responsible for product quality across a portfolio of topical skincare products that include Natural Health Products, Cosmetics, Homeopathic and Over the Counter (OTC) Drugs.
• Responsibilities: List up to 10 main responsibilities for the job. Include information about the accountability and scope.
• Responsible for various aspects of quality assurance and quality control related to products produced.
• Ensures that product is consistently manufactured in conformance with Quality System requirements and all applicable regulatory requirements.
• Supplier oversight, assuring responsible Third Parties are complaint with cGMPs, regulatory and corporate compliance requirements and contractual agreements as applicable.
• Assist project teams in planning new product launches and tech transfer.
• Ensure proper integration and support of quality regulations: drug, biologics, device and/or combination products.
• Assist project teams in planning, preparation, review and approval of quality documentation.
• Responsible for developing a process to maintain citation history.
• Monitor changes to legislation, regulations and statutes that may impact retention and/or require changes to the Record Retention Schedule.
• Create quality system documentation and specifications with guidance from technical teams following approved templates and guidelines.
• Complete and route change requests for process document creation, maintenance, and implementation.
• Design effective quality systems, procedures and/or processes within cross functional teams to ensure compliance as well as efficiency throughout our quality system.
• May be required to prepare and present data during regulatory audits (FDA, EMA, Anvisa, etc) and internal audits.
• Interact with internal and external partners for development of best practices in our quality systems and procedures.
• Perform assessments to determine compliance to processes and regulations to identify potential gaps and mitigate and implement improvements within our quality system.
• Contribute and prepare training and education programs for various aspects of quality assurance.
• M-F 8:30-5:00
  
  

Qualifications

• Knowledge of Cosmetic and OTC product regulations and guidance, including new product introductions and tech transfer highly preferred.
• Ability to work in a team, both in person and remotely, and across various departments.
  
  

California Fair Chance Act

Synectics Inc. will consider qualified applicants with a criminal history pursuant to the California Fair Chance Act. You do not need to disclose your criminal history or participate in a background check until a conditional job offer is made to you. After making a conditional offer and running a background check, if Synectics Inc. is concerned about conviction that is directly related to the job, you will be given the chance to explain the circumstances surrounding the conviction, provide mitigating evidence, or challenge the accuracy of the background report. Find out more about the Fair Chance Act by visiting calcivilrights.ca.gov/fair-chance-act/.

Benefits

Healthcare Insurance: Synectics offers eligible employees and their dependents healthcare coverage through BlueCross BlueShield of Illinois. Eligibility begins on the 1st day of the calendar month following 60 days of continuous full time employment with Synectics. Premiums are subsidized by Synectics.

Dental Insurance: Synectics offers eligible employees and their dependents a dental plan through MetLife. Eligibility begins on the 1st day of the calendar month following 60 days of continuous full time employment with Synectics.

Vision Insurance: Synectics offers eligible employees vision insurance through VSP. Eligibility begins on the 1st day of the calendar month following 60 days of continuous full time employment with Synectics.401(k) Plan: The Synectics Inc. Investment Savings Retirement Plan. Synectics offers all employees who are 21 years of age or older the opportunity to invest in the 401(k) Plan on the first enrollment date that is at least 30 days after employment begins. Enrollment dates are each January 1st, April 1st, July 1st, and October 1st.

Technical Certification Bonus: Synectics is pleased to award its employees a bonus of up to $500 for an approved professional certification. In determining the bonus amount, Synectics will consider the cost of the test(s) for any certification relating to your current position, achieved during your employment with us. Only one Certification Bonus per calendar year may be awarded per employee. Only current, active employees will be eligible to receive this bonus. It will be awarded 90 days after the Synectics office has received documentation confirming the successful completion of the certification.

Synectics is an equal opportunity employer.