Supervisor, Chemical Control

GRIFOLS, S.A.•CA-Los Angeles, CA

4d•Onsite

About The Position

The QC Chemistry Supervisor is responsible for the daily activity of a GMP compliant lab which performs various chemical and biochemical assays on protein-based therapeutics and raw materials to support the release of intermediates and finished products. The supervisor is responsible for delegating daily tasks and ensuring that all tests are executed appropriately and reviewed in a timely manner. The supervisor provides hands-on training of laboratory analysts to enhance work knowledge and productivity.

Requirements

Bachelor’s degree in Chemistry, Biochemistry, Biology or closely related scientific discipline is required.
Minimum of 4 years of related chemistry experience in a pharmaceutical, GMP, or FDA regulated testing laboratory is required.
Requires an in depth understanding of analytical methodologies and protein biochemistry (e.g. IC, HPLC, GC, etc.).
Comprehensive knowledge and understanding of cGMPs, FDA regulations, and industry guidelines.
Prior supervisory or leadership experience is highly preferred.
Demonstrated ability to inspire high performance in others and align team members around shared goals.
Demonstrated leadership skills with the ability to motivate, guide, train, coach and develop department personnel.
Demonstrated project management skills.
Strong organizational, analytical, and problem-solving skills with the ability to make structured decisions on a routine basis.
Must be proactive, results oriented, and have strong attention to detail.
Self-starter with strong work ethic and the ability to exercise good judgment.
Ability to effectively prioritize and manage multiple tasks to meet targeted deadlines.
Strong interpersonal skills with the ability to interact with personnel at all levels in a team environment.
Excellent verbal and written communication skills in the English language.
Computer literacy with proficiency in MS Office (Outlook, Word, Excel, PowerPoint).
Must be flexible with working hours / shifts in order to accommodate the 24 hour, 7 day plant operation.

Responsibilities

Conduct validation studies in accordance with current industry standards and guidelines for the qualification and validation of manufacturing systems and supporting processes.
Develop qualification and validation protocols for manufacturing systems and equipment such as ultra-filtration units, chromatography columns, automation controls, utilities, clean rooms, temperature controlled areas, pasteurizers, lyopholizers, etc.
Execute approved studies and protocols to gather data.
Analyze the resulting data and develop the final validation report.
Responsible for completion of studies within validation project time lines. Assists in the development of the time lines and communicates project updates within the validation department.
Investigate and document all validation related deviations and determine assignable cause.
Maintain current knowledge of regulatory and industry standards.
Generate thorough written reports, when required, that summarize investigations performed for out-of-specification results or out-of-procedure events.
Participate in regulatory and internal inspections/audits including providing written responses as applicable for area of responsibility.
Strict adherence to procedures and practices according to FDA regulations.
Strong emphasis on documentation according to FDA regulations.
Adhere to departmental corporate safety policies.