Validation Specialist at Yoh in New Brunswick, New Jersey

Job Description:

Are you actively seeking for a new REMOTE position as VALIDATION SPECIALIST or know someone that is* I have a CONTRACT opportunity with an American pharmaceutical company that manufactures prescription pharmaceuticals and biologics in several therapeutic areas, including cancer, HIV/AIDS, cardiovascular disease, diabetes, hepatitis, rheumatoid arthritis, and psychiatric disorders. If you meet the requirements, please send me your updated resume to RACHITA.SAXENA@YOH.COM. "YOU MUST BE ELIGIBLE TO WORK IN THE US WITHOUT SPONSORSHIP."

6 MONTH CONTRACT

PAY RATE: $50-$54/HR

Position will be remote. Candidate can be located anywhere to fill this role.

Candidate MUST BE fluent in Spanish, verbal and writing, in addition to English.

DESCRIPTION:

Pharmaceutical External Manufacturing Americas - Quality Operations

Provides support of packaging validation, Quality Assurance oversight and Product Release functionality for drug products manufactured by the Contract Manufacturer. Primary responsibility is to support packaging validation activities to ensure that BMS products packaged by Contract Manufacturer are operating in compliance with all Bristol-Myers Squibb Co. and applicable FDA and international regulatory standards. In addition, this position has responsibility to ensure that released products comply with Bristol-Myers Squibb Co. internal and government (FDA or specific market) requirements and support Quality Systems processes.

* Support packaging tech transfer

* Provide reviews and approvals for validation/transfer protocols, reports, and other related documents

* Review and approve change requests

* Investigate and/or evaluate manufacturing and laboratory deviations or incidents.

* Determines disposition of drug products according to BMS and regulatory specifications and standards

* Write, review and implement SOPs to ensure compliance with current BMS standard and cGMP.

* Supports product recalls and executes plan as assigned

* Participate in audits (For Cause) of North American External Manufacturers of drug products ensuring compliance with all appropriate BMS and FDA and EMA agency cGMP regulations and policies.

* Represent Quality on cross-functional teams within the project team

REQUIREMENT:

* Experienced with serialization for global markets

* Knowledge in solid dosage forms, biologics or combination products.

* Knowledge of compendia and cGMP requirements, FDA regulations and the ability to interpret and apply them.

* Proficiency with the use of global systems (e.g., TrackWise, SAP).

* Excellent verbal and written communication skills in Spanish and English

* Excellent interpersonal skills.

* Capable to manage multiple priorities.

* Able to rapidly adapt to changing environment and circumstances requiring flexibility, tolerance and great sense of urgency while ensuring that all cGMP and Regulatory requirement are met.

* Trained in auditing techniques and skills such as observation, questioning, and assessment of complex problems.

* B.S. in Natural Sciences, Chemistry, Microbiology, Biology, or Pharmacy

* A minimum of 7 years experience in pharmaceutical, biologics, biotech or related industry with relevant experience.

* Experience in a Quality Assurance or Quality Control function is required.

* Experience in packaging of drug product is desired.

Opportunity is Calling, APPLY NOW!

RECRUITER: Rachita Saxena: Rachita.Saxena@yoh.com

WHAT'S IN IT FOR YOU*

We welcome you to be a part of one of the largest global staffing companies to meet your career aspirations. Yoh's network of client companies has been employing professionals like you for over 65 years in the U.S., UK and Canada. Join Yoh's extensive talent community that will provide you with access to Yoh's vast network of opportunities and gain access to this exclusive opportunity available to you.

* Medical, Dental & Vision Benefits

* 401K Retirement Saving Plan

* Life & Disability Insurance

* Direct Deposit & weekly ePayroll

* Employee Discount Programs

* Referral Bonus Programs

Yoh, a Day & Zimmermann company, is an Equal Opportunity Employer, M/F/D/V. Click here:
http://www.yoh.com/applicants-with-disabilities
to contact us if you are an individual with a disability and require accommodation in the application process.

Apply Now