Description:Agilent inspires and supports discoveries that advance the quality of life. We provide life science, diagnostic and applied market laboratories worldwide with instruments, services, consumables, applications and expertise. Agilent enables customers to gain the answers and insights they seek so they can do what they do best: improve the world around us. Information about Agilent is available at www.agilent.com.
The world s most revolutionary biopharma companies are partnering with Agilent Technologies to advance the next frontier of medicine. Agilent continues to invest in capacity and expansion of its Colorado operations. Join our team of professionals dedicated to the development and commercialization of nucleic acid therapeutics for life changing, lifesaving medicines.
The Compliance Specialist monitors and audits Good Manufacturing Practice (GMP) activities to ensure compliance with applicable regulatory requirements and Standard Operating Procedures (SOPs) by conducting audits of GMP activities against SOPs, and associated records. This includes on the floor auditing as per procedure and assisting with internal audit functions as requested by management.
ESSENTIAL DUTIES AND RESPONSIBILITIES:
Conducts on the floor document reviews and audits of the GMP facility as per company procedure to assure company SOPs and standards are maintained (strength, quality, purity, etc) and product integrity is preserved. Assists in the generation and completion of deviations, corrective actions and change controls as needed, including on-the-spot corrections. Documents significant findings as per company SOP.
Assists, as requested by management, in conducting internal audits as per company procedure using a system based approach to assure company SOPs and standards are maintained (strength, quality, purity, etc) and product integrity is preserved. Writes audit reports and assists in the generation and completion of corrective actions for findings from audits.
Consults with Manufacturing Management to resolve, Compliance related issues.
Assists staff members with troubleshooting, investigating and resolving deviations, closing out discrepancies and assigning corrective actions.
Writes, reviews, and approves documentation as needed.
Provides support on various other manufacturing assurance issues as necessary, ensuring the precision, accuracy, and reliability of company products.
This job has no managerial responsibilities but often makes recommendations on hiring, training, scheduling of work tasks, and coaching of employees. This position is eligible to perform duties of the Manufacturing Manager as the Designee if appropriately trained.
KNOWLEDGE, SKILLS, AND ABILITIES:
To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
Knowledge of GMP guidelines as well as international regulations pertaining to the production of APIs and drug products.
Knowledge and understanding of the oligonucleotide manufacturing or related pharmaceutical manufacturing processes.
Experience in performing internal and external audits in a GMP environment.
Skill in communication, written and verbal; will be handling various relations issues and will be confronted with various interactions
Knowledge of and skill in using computer software and hardware applications, including Microsoft products and the Internet.
Skill in managing various projects; must be able to use individual discretion in completing work assignments; while assisting the group in establishing priorities, setting standards and working collectively to accomplish deadlines and objectives
Ability to read, analyze, and interpret industry related periodicals, SOPs, and government regulations. Ability to write reports, business correspondence, and procedures. Ability to respond to common inquiries or complaints from customers, co-workers, subordinates, and supervisors regarding the products and processes.
Description:Qualifications:EDUCATION and/or EXPERIENCE:
Bachelor's degree (B.S.) or equivalent in chemistry or related life sciences field;
3+ years related experience/and or training: or equivalent combination of education and experience.
Prior experience and/or training working in a GMP production environment is preferred
While performing the duties of this job, the employee is regularly required to sit, stand and walk.
The employee is occasionally required to use hands to finger, handle, or feel; and reach with hands and arms.
The employee must occasionally lift and/or move up to 50 pounds.
This employee may be required to perform shift work.
Agilent Technologies, Inc. is an Equal Employment Opportunity and Affirmative Action employer. We value diversity at all levels. All individuals, regardless of personal characteristics, are encouraged to apply. All qualified applicants will receive consideration for employment without regard to sex, pregnancy, race, religion or religious creed, color, gender, gender identity, gender expression, national origin, ancestry, physical or mental disability, medical condition, genetic information, marital status, registered domestic partner status, age, sexual orientation, military or veteran status, protected veteran status, or any other basis protected by federal, state, local law, ordinance, or regulation and will not be discriminated against on these bases.
For more information about equal employment opportunity protections, please view the EEO is the Law poster available here:
Agilent Technologies, Inc., is committed to diversity in the workplace and strives to support candidates with disabilities. If you have a disability and need assistance with any part of the application or interview process or have questions about workplace accessibility, please contact +1-262-###-#### (US and Canada only) or email ...@agilent.com. EOE AA M/F/Vet/DisabilityQualifications:
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