What are the responsibilities and job description for the Senior Analytical Chemist position at TCP Analytical?
About the Company
Barker Industries, a TCPA Company is a manufacturer of High Purity Chemicals for the pharmaceutical, electronic, aerospace and research and development industries.
About the Role
The Analytical Quality Chemist will perform assigned functions relevant to the laboratory area ensuring that quality is maintained in products.
Responsibilities:
Quality Control Testing:
- Perform analytical testing related to raw material testing, in-process testing, finished goods testing and stability testing.
- Support inspections of components such as packaging components.
- Perform various testing analyses as per analytical methods, compendial requirements or recognized standards (such as ACS, USP, EP, JP, NF, etc.).
- Analysis of samples using wet chemistry or instrumentation including melting point apparatus, titration assays, pH, loss of drying, Karl Fisher, identification by FTIR, total organic carbon, UV-vis instrument.
- Analysis of samples using more complex instrumentation including ICP-OES, atomic absorption, and HPLC.
- Analysis of samples for bioburden testing and endotoxin testing.
- Adhere to instructions as detailed in formulation records and analytical test methods.
Quality Support Functions:
- Report and review data, ensuring data meets specifications, compliance requirements, and data integrity such as raw data attached.
- Calibrating, maintaining, and operating all standard laboratory equipment, for example: titrators, pH meters, balances, etc.
- Preparation of certified standards and proper preparation of secondary standards.
- Prepare labels for laboratory products, laboratory standards and ensure within expiration date.
- Prepare product labels and support label accountability program.
- Prepare C of A’s for products based on established specifications.
- Provide legible and accurate written information to general laboratory documentation.
- Perform and ensure thorough, routine cleaning of lab equipment and glassware, including proper disposal of emptied containers and their packaging.
- Support authoring of analytical test methods and specifications.
Continuous Improvement and Projects:
- Support OOS, CAPA or deviation investigations using root cause analysis tools.
- Support developmental or bench scale laboratory studies for new products or continuous improvement projects.
- Support documentation of technical reports.
- Report deviations or OOS that are observed.
- Support validation activities for process validation or test method validation activities.
- Support quality or operational projects for compliance or potential new business opportunities.
- Identify and drive process improvements within the quality function, working to streamline testing and improve product quality.
- Support other duties or projects as requested by management.
Compliance and Standards:
- Ensure that all products and services meet regulatory and compliance requirements.
- Maintain knowledge of relevant industry standards and best practices (e.g., ISO, FDA, etc.) and integrate them into the QC processes.
- Monitor the USP, NF, EP, JP, and ACS for updates and incorporate updates as required.
- Support audit activities as requested.
Qualifications
- Education: Bachelor’s degree in chemistry, Biology, or science related field.
- Experience: 5 years of experience in quality laboratory environment. Experience in a regulated industry preferred (e.g., manufacturing, pharmaceuticals, healthcare). Experience with wet chemistry and general laboratory instrument (required). Experience with ICP, HPLC and AA instrumentation (preferred).
Required Skills
- Strong understanding of analytical testing methods and instrumentation.
- Familiarity with relevant industry standards and regulatory requirements (e.g., ISO9001, FDA, USP, NF, FCC).
- Attention to detail and proven ability to follow written procedures.
- Commitment to data quality including proven ability to accurately record data.
- Strong team player, working in a collaborative team environment and ability for managing multiple priorities.
- Good communication skills and technical writing skills.
- Strong problem-solving skills, attention to detail, and ability to learn quickly.
Preferred Skills
- Experience with ICP, HPLC and AA instrumentation.
Equal Opportunity Statement
We are an Equal Employment. We do not discriminate in hiring on the basis of sex, gender identity, sexual orientation, race, color, religious creed, national origin, physical or mental disability, protected Veteran status, or any other characteristic protected by federal, state/province, or local law.