Quality Control Validation Scientist

Job Description

Job Description

Description:

• As a QC Analytical Scientist, you will support various Quality Control activities within the AQC department.

• Transfer and execute analytical methods, including raw materials, for use in a cGMP environment in Quality control, both analytical quality control methods (AQC) and Quality Control Microbiology methods (QCM).

• Drive analytical method validation/ transfer of laboratory methodologies

• Support the execution and issue resolution (e.g., discrepancies) and completion approval of test plans/protocols

• Support troubleshooting of analytical methods

• Ensure laboratory equipment is maintained in a validated state and that all analytical methods transferred follow company and regulatory requirements.

• Responsible for protocol and report generation and other technical documents as required.

• This may include supporting raw material qualification for new products

• Use sound scientific principles and statistical techniques to solve problems and make recommendations.

• May Support the installation, operational qualification (IOQ), maintenance and troubleshooting of instrumentation in the AQC group.

• Responsible for deliverables to ensure timelines and milestones are met.

• May need to work in controlled or clean room environments requiring special gowning.

• May work around chemicals such as alcohol, acids, and buffers that may require respiratory protection.

• Able to work more than 8 hours a day or 40 hours a work week as needed.

Qualifications

• Bachelor's Degree in biotechnology, Microbiology, Pharmacy, Chemistry or equivalent.

• Minimum of 1 year of analytical development or validation experience in Pharmaceutical, Biopharmaceutical or related manufacturing environment, or an advanced degree.

• Strong technical writing skills and able to write generate technical documents and reports that meet company and regulatory requirements

• Knowledge of analytical methods and operations with strong emphasis in problem-solving.

• Knowledge about analytical method validation.

• Intermediate statistical knowledge and experience with data analysis

• Knowledge concerning cGMP, especially lab related topics such as method validation and unexpected results investigation.

• Basic knowledge about regulatory requirements concerning analytical instrumentation, and test methods

• Substantial knowledge and understanding in terms of regulatory standards requirements e.g., CGMP, QSR, USP, 21CFR, ICH etc.

• Ability to complete tasks with minimal direction, demonstration of basic project management skills.

• Ability to multi-task in a highly dynamic and diverse environment.

• Attention to detail, good organization, and time management skills to meet deadlines.

• Proficient in Microsoft Office.

• Strategically and business-oriented thinking

• Nice to have the KNEAT Program, not required

• Experienced in reviewing and approving Life Cycle Validation Documents including:

• Familiar with paperless validation software for life sciences

• Commissioning, Installation, Operational and Performance Qualification protocols and reports for Equipment, Facilities & Utilities at Biopharmaceutical Manufacture plant.

• Computer System Validation protocols and reports, including SCADA, MES.

• QC/Micro Laboratory Instrument Qualification and method validation.

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 of the month following at least 1 calendar year after employment begins.

Synectics is an equal opportunity employer.

\nCompany Description

Synectics is a leading staffing and workforce solutions company dedicated to connecting exceptional talent with top organizations. We specialize in IT, engineering, finance, healthcare, and professional services recruitment, offering both contract and permanent staffing solutions. With a people-first approach, we focus on understanding the unique needs of our clients and candidates to create long-term, successful matches. Our mission is to empower businesses with the right talent while helping professionals achieve rewarding career opportunities

Company Description

Synectics is a leading staffing and workforce solutions company dedicated to connecting exceptional talent with top organizations. We specialize in IT, engineering, finance, healthcare, and professional services recruitment, offering both contract and permanent staffing solutions. With a people-first approach, we focus on understanding the unique needs of our clients and candidates to create long-term, successful matches. Our mission is to empower businesses with the right talent while helping professionals achieve rewarding career opportunities