QA Manager I Miami Lakes, FL
About Albion Staffing Solutions:
Albion has been offering Temp; Contract and Direct Hire Staffing Services for 20-years from offices located throughout South Florida. Offering General Admin/Clerical and Light Industrial staffing services, Albion also specializes in the Logistics, Allied Healthcare and Banking industries.
About this Position:
Albion is seeking QA Manager for a company in the Miami Lakes, FL Area. Overall responsibility for the management of a QA department which includes managing the staff by providing guidance, CGMP/ Quality System/Safety training and coaching.
- Implement and manage the Quality Management System (QMS).
- Functions Independent from Laboratory operations where QA oversight is provided.
- Serve as a resident Quality expert in support of QMS activities (GLP, GCP, and CUA).
- Maintain knowledge of CGMP, ISO, GLP, and other Quality Systems as required by clients and regulatory authorities.
- Ensures that the management system related to Quality is implemented. This includes monitoring key performance indicators such as Deviations, OOS/OOT Investigations, CAPA, Complaints, Turn-Around-Time, Change Control, Audit result.
- Maintains the Quality Manual and conducts Management Reviews and Internal Quality Audits on a periodic basis to provide statics on QMS metrics.
- Responsible for all audit functions within GPA. Act as a host to auditing personnel as required ensuring staff response to internal and external plans are maintained, conducted, reported, and responded to in a timely manner.
- Direct the training program to support CGMP/ISO activities in laboratory operations.
- Manage Document Control system, including the Engineering Change Order process
- Author and review QMS SOPs.
- Manage change control, CAPA, deviation, Non-conforming Product, SCAR, audit findings and investigation programs.
- Oversee the internal and external audit program, which includes, focus on GxP, GLP, GCP, CUA compliance, regulatory agency inspection readiness, and for-cause inspections.
- Manage Calibration Program.
- Provide support to Clinical Team and Laboratory to ensure compliance with GCP's, GLPs and applicable regulatory requirements.
- Provide support for vendor, site and internal GCP audits and insure GCP compliance.
- Develops processes and guidelines for quality system management and oversees continuous improvements to ensure enhanced compliance to CGMPs and evolving FDA expectations.
- Schedule perform and/or support audits of clinical sites, CROs and other clinical vendors.
- Supplier management, including maintaining the Approved Supplier List.
- Assist in the development of Quality Agreements with GCP vendors.
- Maintain relationships with vendors, contractors, and consultant to ensure effective execution of assigned tasks.
- Achieves financial objectives by preparing the quality assurance budget, scheduling expenditures, analyzing variances, initiating corrective actions.
- Responsible for records management and facilitation of off-site records storage.
- Maintain the personnel training records.
- Assist in the development of Quality Metrics, and coordinate quality data collection and analyses for use in Management Reviews.
- Reviews final reports to assure the reported test result were verified and approved by technical personnel and that results are reported to reflect the raw data.
- Oversees tracking and trending of quality systems and present information/reports to senior level management
- Requires a Bachelor's (Master's degree preferred) in a related scientific discipline. Minimum of 7+ years' work experience in QA in a GxP regulated environment. 2+ years supervisory experience.
- Must have successful implementation experience and management of a QMS System.
- Broad knowledge of clinical processes and procedures, electronic documentation systems, and Good Clinical Practices 21CFR Parts 50, 56, and 312.
- Must demonstrate attention to detail and excellent record keeping skills.
- Must be proficient in MS Office Suite (e.g. Word, Excel, PPT) required for review and preparation of documents and reports for inspections.
- Proven ability to find creative, practical solutions to complex problems.
- Excellent communication and interpersonal skills.
- Superior and proven organizational skills.
- Ability to multitask and work in a team-oriented fast-paced environment.
Requires a Bachelor's (Master's degree preferred) in a related scientific discipline certification as Lead Auditor preferred.
- Health insurance
- Dental insurance
- Vision insurance
- Retirement plan
- Paid time off
Applicants will work in the Miami Lakes, FL Area
* Pre-Employment and random Drug and Background testing may be applicable.
* Only Local Candidates will be considered; no relocation provided
Pay: from $60,000/year
Job Status: Full Time