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The QA Compliance Manager is responsible for the inspection readiness program for the assigned site. Inspection readiness may include periodic internal audits, client audits, or any external agency inspections like the FDA. Has the responsibility to lead audits as well as serve as the primary quality representative during external agency or client audits. Accountable to the client and/or agency for audit observations responses and the associated corrective measures. or GMP/GDP audits (for Client, Regulatory & Internal).
The QA Compliance Manager works collaboratively with other members of the site, and the clients functional areas and leadership teams to evaluate GMP/GDP business operations for compliance with health authority requirements, SOPs, and procedures, to ensure product quality and patient safety
Responsibilities:Skills / Abilities:
Full Time
$110k-138k (estimate)
06/16/2024
07/02/2024
cambrex.com
SALISBURY, MD
1,000 - 3,000
1981
NICK SHACKLEY
$500M - $1B
Ancillary Healthcare
Cambrex is the small molecule company that provides drug substance, drug product and analytical services across the entire drug lifecycle. Enjoy working with our experts to accelerate your small molecule therapeutics into the market. With over 40 years experience and a growing team of over 2,100 experts servicing global clients from sites in North America and Europe, Cambrex is a trusted partner in branded and generic markets for API and dosage form development and manufacturing. Cambrex offers a range of specialist drug substance technologies and capabilities including biocatalysis, continuou ...
s flow, controlled substances, solid state science, material characterization and highly potent APIs. In addition, Cambrex can support conventional dosage forms including oral solids, semi-solids and liquids and has the expertise to manufacture specialist dosage forms such as modified-release, fixed dose combination, pediatric, bi-layer tablets, stick packs, topicals, controlled substances, sterile and non-sterile ointments.
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The following is the career advancement route for QA Compliance Manager positions, which can be used as a reference in future career path planning. As a QA Compliance Manager, it can be promoted into senior positions as a Quality Assurance Senior Manager that are expected to handle more key tasks, people in this role will get a higher salary paid than an ordinary QA Compliance Manager. You can explore the career advancement for a QA Compliance Manager below and select your interested title to get hiring information.