Quality Control Analytical Scientist

Description:

• As a QC Analytical Scientist II, 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 analyticalquality control methods (AQC) and Quality Control Microbiology methods (QCM).

• Drive special projects that require AQC attention/leadership.

• Drive analytical method development and validation of laboratory methodologies and instrumentation. This includes leading analytical/microbiology QC efforts to support the introduction of new product testing, modifying existing laboratory space, plan design new laboratory spaces and working with vendors to purchase new instruments, and the installation and qualification of new instruments.

• Support investigations and manufacturing investigations requiring analytical method support.

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

• Serve on project teams, in a leadership role as needed, which will require substantial interaction and communication with other group functions.

• Upgrading of analytical technologies within an established licensed technology platform.

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

• Support troubleshooting of analytical methods and instruments and support laboratory investigations as needed to provide scientific justification for initial Out of Specification (iOOS), Out of Trend (OOT), and atypical result investigations

• Review and approve laboratory investigations, deviations, CAPAs, and periodic reviews, and other documentation that requires advanced analytical knowledge.

• Ensure all 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 as well as authoring CMC submission and other technical documents as required. This includes supporting raw material qualification for new products

• Manage and perform assay control and critical reagent qualifications, including monitoring and trending of method performance.

• Support the analysis of QC data using statistical tools to identify trends and set limits for results, including data transcription/entry

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

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

• Support scheduling of AQC and QCM testing (release, execution of protocols, etc.).

• Lead small teams as needed to accomplish tasks.

• Representative for Analytical projects with global and local site functions. Ensure Right

• First Time (RFT) in the method introduction and instrument qualification process

• Other duties as assigned.

Qualifications

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

• Minimum of 3 years of analytical development or validation experience in GMP Pharmaceutical, Biopharmaceutical or related manufacturing environment, or anadvanced degree.

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

• In depth knowledge of analytical methods and operations with strong emphasis in problem-solving.

• Knowledge about analytical method validation and critical reagent qualification.

• Intermediate statistical knowledge and experience with data analysis.

• Knowledge concerning cGMP, especially lab related topics such as method validation and 2 unexpected results investigation.

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

• 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.

• Strategic and business-oriented thinking.

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.

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