- Experience in the manufacture of drug substance and/or drug product or quality control laboratories is desired
- Knowledge in solid dosage forms, parenteral technology, biologics or combination products
- Knowledge of compendial and cGMP requirements, FDA regulations and the ability to interpret and apply them
- Proficiency with the use of global systems (e.g., Systems, Applications and Products (SAP), Document Control and Archiving (DCA)).
- Good verbal and written communication skills essential
- 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
- Manages CMO relationships from a quality and compliance perspective, including monitoring quality metrics, performing annual risk assessment of CMOs and executing oversight as defined by Standard Operating Procedures (SOP s), authoring and executing Risk Mitigation Plans as needed
- Determines disposition of drug products according to Client and regulatory specifications and standards
- Review change requests generated internally or by External Manufacturer
- Reviews Annual Product Quality Reviews (APQR s) authored by Contract Manufacturers/Packagers and supplement APQR s as required
- Investigate and/or evaluate manufacturing, packaging and laboratory deviations or incidents and associated Corrective and Preventive Actions (CAPA s) and provide direction and recommendations as to future course(s) of action
- Review Quality Agreements
- Review and approve product quality complaint investigations
- Review and approve validation/qualification protocols and reports from the External Manufacturer as defined in related Quality Agreements
- Write, review and implement SOP s to ensure compliance with current Client standard and current Good Manufacturing Practices (cGMP)
- Participate as required on Fact Finding Investigation Team (FIT and Fact Finding Investigation Review Meetings (FIRM)
- Supports product recalls and executes plan as assigned
- Represent Client during FDA/other regulatory inspections and corporate GMP compliance audits as defined in related Quality Agreements
- Assist with preparation of audit observations
- Participate in audits (For Cause) of North American External Manufacturers of drug products ensuring compliance with all appropriate Client and FDA and European Medicines Agency (EMA) cGMP regulations and policies
- Represent Quality on crossfunctional teams within the "Virtual Manufacturing Plant", Technical Transfer teams, Supplier Selection, Serialization Manufacturing and Packaging launch teams
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Quality assurance specialist
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Children's Aid Society Manhattan, NY, United States· Refer · Save · Apply · Job ID: 007006 · Description: · Harlem Family Services Center (317 Lenox Ave) · $ $65000 / year · About Children's Aid: For more than 160 years, Children's Aid has been able to help families change their lives by adapting to the ever evolving nature of p ...
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Finish Line Hudson, United States Full timeIs maintaining the highest standards of quality in product engineering important to you? Are you the kind of person who can spot a flaw from a mile away? Would you like to be part of a game-changing team that brings innovative ideas to life? If so, you are in the right place · At ...
Quality Assurance Specialist - New Brunswick, United States - Artech LLC
Description
Quality Assurance SpecialistNew Brunswick, NJ 100% Onsite
Pay Rate Range:
$44 - $45.24/hr W2
Required Skills:
- B.S. in Natural Sciences, Chemistry, Microbiology, Biology, Engineering, Pharmacy or equivalent
- A minimum of five (5) years experience in pharmaceutical, biologics, biotech or related industry with relevant experience with
batch record review, deviation and change control oversight experience
- Experience in a Quality Assurance, Quality Control or equivalent function is required
Job Description:
ALPHA S REQUIREMENTS
MUST BE ELIGIBLE TO WORK IN THE U.S. AS AN HOURLY W2 EMPLOYEE
