NewBrunswickRecruiter Since 2001
the smart solution for New Brunswick jobs

Quality Operations for Pharmaceutical Manufacturing (bilingual Spanish)

Company: Alpha Consulting
Location: New Brunswick
Posted on: January 12, 2021

Job Description:

QUALITY OPERATIONS FOR PHARMACEUTICAL MANUFACTURING (BILINGUAL SPANISH)NEW BRUNSWICK, NJCandidate MUST BE fluent in Spanish, verbal and writing, in addition to English.Project Description: 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 Client products packaged by Contract Manufacturer are operating in compliance with all Client and applicable FDA and international regulatory standards. In addition, this position has responsibility to ensure that released products comply with Client 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 Client and regulatory specifications and standards.* Write, review and implement SOPs to ensure compliance with current Client 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 Client and FDA and EMA agency cGMP regulations and policies.* Represent Quality on cross-functional teams within the project team Required Skills:* 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. This 6+ month position starts ASAP.Please E-MAIL your resume (attachment to email) with rate and availability to Bridget: bridget@alphaconsulting.com ALPHA'S REQUIREMENT #21-00034MUST BE ELIGIBLE TO WORK IN THE U.S. AS AN HOURLY W2 EMPLOYEE#ZR

Keywords: Alpha Consulting, New Brunswick , Quality Operations for Pharmaceutical Manufacturing (bilingual Spanish), Other , New Brunswick, New Jersey

Click here to apply!

Didn't find what you're looking for? Search again!

I'm looking for
in category
within


Other Other Jobs


Salesforce Administrator
Description: Located in Hauppauge, Long Island, NY br Since 2000, AccountantsWorld has found innovative ways for accountants to benefit from the cloud and other emerging technologies. Simply put, our purpose is (more...)
Company: AccountantsWorld
Location: Hauppauge
Posted on: 01/19/2021

RN / Registered Nurse / New York / Any / Family Nurse Practitioner - F
Description: FAMILY NURSE PRACTITIONER NEEDED ON LONG ISLAND
Company: KA Recruiting, Inc.
Location: Bohemia
Posted on: 01/19/2021

Fork Lift Operator (I)
Description: Company DescriptionThe Nature's Bounty Co. is a privately held, global leader in health and wellness with a rich history and proven track record in the nutritional market. As a manufacturer, marketer (more...)
Company: The Nature's Bounty Co.
Location: Bohemia
Posted on: 01/19/2021


Family Communication Specialist (PT) (Bilingual Preferred) - Home Base (Intensive)
Description: EAC Network seeks a Family Communication Specialist Bilingual preferred to work for the Home Base Intensive Program. The position is Part-Time, up to 19 hours per week. Primary Purpose of Job: The (more...)
Company: EAC Network
Location: Hauppauge
Posted on: 01/19/2021

Associate Relations Partner (Bilingual)
Description: Piping Rock Health Products growing Human Resources department is actively searching for an Associate Relations Specialist to join our team As an Associate Relations Specialist, you will assist with (more...)
Company: Piping Rock Health Products
Location: Bohemia
Posted on: 01/19/2021

Hiring Immediately: Coca Cola
Description: Easy Application
Company: Coca Cola.com
Location: Holtsville
Posted on: 01/19/2021

Deliver Food with Uber - Flexible Gig
Description: Job DescriptionDeliver with Uber. Earn on your schedule. Work on your schedule. Deliver for a few hours in the mornings, every night, or just on weekends--it's up to you. Earn Good Money. You'll
Company: Uber Eats
Location: Bayport
Posted on: 01/19/2021

Installation Contractor
Description: Job DescriptionLeafFilter Gutter Protection Installers needed for immediate work as independent contractors. We provide in-depth knowledge so you can correctly and efficiently install our gutter protection (more...)
Company: LeafFilter
Location: Hauppauge
Posted on: 01/19/2021

Family Nurse Practitioner - Urgent Care (Nurse Practitioner #)
Description: Urgent Care opening in Medford, New York. Full-time Family Nurse Practitioner needed at
Company: KA Recruiting Inc.
Location: Medford
Posted on: 01/19/2021

Need a gig? Deliver with Uber Eats!
Description: Job DescriptionDeliver with Uber. Earn on your schedule. Deliver with Uber Eats on your schedule. Deliver for a few hours in the mornings, every night, or just on weekends--it's up to you. Earn Extra (more...)
Company: Uber Eats
Location: Mastic
Posted on: 01/19/2021

Log In or Create An Account

Get the latest New Jersey jobs by following @recnetNJ on Twitter!

New Brunswick RSS job feeds