Quality Assurance - Filled Vial & Syringe - Newark, DE

Ensure aseptic manufacturing of biopharmaceuticals in containers and packaging complies with Quality Assurance and applicable regulatory requirements by assisting with audits, training programs, and documentation review.

*** Create, revise, and review Standard Operating Procedures including compliance documentation initiation, revisions, and deletions.

*** Assist training of new employees and other technical personnel.

*** Review production batch records and associated data for product release.

*** Determine if records are within range of cGMP regulations.

*** Review data obtained for compliance specifications and report abnormalities.

*** Evaluate impact of deviations and adverse events to product quality.

*** Create cGMP labels, and review and reconcile cGMP label generation.

*** Conduct cGMP audits including audit preparation, execution, reporting, and follow up.

*** Perform logbook documentation audits for cGMP regulated logs and SOPs.

*** Support quality functions and potential issues for assigned clients.

*** Interact with clients to follow up on client inquiries and complaints.

Join a passionate and talented team in a rapidly growing company while earning a competitive compensation package with bonuses and excellent benefits including: company paid full family coverage medical, dental, prescription and vision, matched 401(k), stock, tuition reimbursement and more.

For complete details contact Christopher Moreno at:
(609) 584-9000 ext 264

Or submit resume online at:
http://dmc9.com/cam/app.asp

Or email to:
1000056071_10007349@najbcareers303.com

Please reference #42721584 when responding.

5+ years

Delaware

$120,000.00

$160,000.00

Christopher Moreno

(609) 584-9000 ext 264

1000056071_10007349@najbcareers303.com

https://dmc9.com/cam/app.asp

WE ARE AN EQUAL OPPORTUNITY EMPLOYER and our employment decisions are made without regard to race, color, religion, age, sex, national origin, handicap, disability or marital status. We reasonably accommodate individuals with handicaps, disabilities and bona fide religious beliefs. Jobs Career Position Hiring. CONSIDERED EXPERIENCE INCLUDES: http://najobbank.com www.najobbank.com Top 10 Job Site Top 10 Careers Site Manager Quality Assurance Director Sterile Manufacturing Aseptic Packaging vials Syringes cGMP GAMP 21CFR Biologics Manufacturing Pharmaceuticals Biopharm Bioprocessing Recombinant Proteins MABs mRNA Lenti AAVs Protein Purification #DiedreMoire #JobSearch #JobHunt #JobOpening #Hiring #Job #Jobs #Careers #Employment #jobposting #QualityJobs #QualityManager

DISCLAIMER: We will make every effort to consider applications for all available positions and shall use one or more of the contact methods and addresses indicated in resume or online application. Indicated location may be proximate or may be desirable point of embarkation for paid or unpaid relocation to another venue. Job descriptions may fit single or multiple presently available or anticipated positions and are NOT an offer of employment or contract implied or otherwise. Described compensation is not definite nor precise and may be estimated and approximate and is negotiable depending on market conditions and candidate availability and other factors and is solely at the discretion of employers. Linguistics used herein may use First Person Singular and First Person Plural grammatical person construction for and with the meaning of Third Person Singular and Third Person Plural references. We reserves the right to amend and change responsibilities to meet business and organizational needs as necessary. Response to a specific posting or advertisement may result in consideration for other opportunities and not necessarily the incentive or basis of the response. Nothing herein is or may be considered a promise, guarantee, offer, pledge, agreement, contract, or oath.

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