Job Description

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

REQUIREMENTS:

  • 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.

 EDUCATIONAL  REQUIREMENTS

 Requires a Bachelor's (Master's degree preferred) in a related scientific discipline certification as Lead Auditor preferred.

Benefits:

  • Health insurance
  • Dental insurance
  • Vision insurance
  • Retirement plan
  • Paid time off

Workplace Location:
Applicants will work in the Miami Lakes, FL Area

Candidate Advice:
* Pre-Employment and random Drug and Background testing may be applicable.
* Only Local Candidates will be considered; no relocation provided