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Biotech Quality Assurance Manager

Company: Monarch Staffing
Location: Reading
Posted on: March 28, 2020

Job Description:

Quality Assurance Manager- Reading area- Direct Hire- $75K+ (Negotiable DOE)The Quality Assurance Manager is responsible for supervising the quality teams, including quality assurance, quality control laboratory, and production quality assurance, to ensure high compliance and productivity.Responsibilities include, but are not limited to the following:- Review and manage all company change controls and planned deviations- Manage and assist in company investigations and implementation of corrective and preventative actions- Write and execute all process and fill validation protocols and summaries- Review and control all formula and fill specifications- Write annual product reviews for all over-the-counter drug products- Conduct annual cGMP training to all employees- Track and report quality metrics to management team- Manage mock recall and internal audit programs- Manage and assist in creating and updating all standard operating procedures- Facilitates all external audits by customers, third parties, and/or regulating bodies Requirements:- Critical and analytical thinking, good problem-solving skills- Strong planning and organizing skills in a fast-paced environment- Good time management and attention to detail- Strong leadership, communication, delegation, and interpersonal skills- Minimum of ten (10) years of experience in the field - Five (5) year of management experience- BS in chemistry or science related field.- Strong working knowledge of cGMP and FDA regulations- Must have strong attention to detail, strong problem-solving skills, as well as the ability to work in a cross-functional team environment. - Knowledge of quality systems, industry standards, and safety

Keywords: Monarch Staffing, Reading , Biotech Quality Assurance Manager, Executive , Reading, Pennsylvania

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