Specialist QA

Juncos, Puerto Rico, Puerto Rico
Full Time
PR Operations
Manager/Supervisor

JOIN OUR TEAM!

PharmaLex is a highly successful and growing consulting company for the Healthcare industry around the world. PharmaLex offers professional development, plus a stimulating and collaborative work environment. We are committed to providing exciting career opportunities in an atmosphere that values trust, respect, teamwork, creative talent, enthusiasm, and diligence.

What we offer:

  • Competitive salaries
  • Ability to earn additional income based on hours worked (Biweekly basis)
  • Free High-Quality webinars provided by experts from around the world
  • Committed to keeping our consultants in project continuity
  • Referral Program
  • Wellness Program
  • Recognition Program (for employees only)
  • Service Award Program (for employees only)
  • Discount Program (for employees only)
  • An administrative team that is oriented in providing excellent service that pursues satisfying the needs of our consultants.
  • For our projects in the US, we cover travel/lodging/transportation expenses (employees only)

RESPONSIBILITIES and EXPERIENCE REQUIRED 
:
• You will perform review, approval and tracking of cGMP processes, procedures, testing (methods) in manufacturing, documents and records, batch record review, MES, EBR, SAP, Trackwise; including but not limited to Deviation’s, CAPAs, and validations
• Actively engage in Continues Improvement initiatives, programs and projects
• Vigilant ensuring that changes that could potentially impact product quality are assessed according to procedures
• Certify that deviations from established procedures are investigated and documented per procedures
• Ensures that production records and testing results are complete, accurate, and documented according to written procedures and cGMP requirements
• To be successful, you will require strong collaboration and partnership cross functionally to ensure the Quality Management System processes are executed in accordance with established procedures
• Strategic advisor to senior management of quality, compliance, supply and safety risks
• Supports internal/external audits and inspections as part of the audit/inspection management team including acting as Quality unit representative as needed
• Accountable for assigned training adherence to permit execution of required tasks
• Champion Continuous Improvement initiatives and projects
• Provides support and oversight of New Product Introduction (NPI)
• Validated expertise in Quality Systems such as Non-Conformance, CAPA, and Change Control
• Experience in computer systems validation or computer systems quality assurance (medical device and/or consulting background Technical proficiency)
• Robust knowledge of and experience with processes involved in manufacturing and distribution, QA, QAL, and Process Development
• Experience with Validation of GxP applications, Validation Master Plan, Installation Qualification (IQ), Risk Assessment/GxP assessment, Operational Qualification (OQ), and Performance Qualification (PQ) Protocols, Test Scripts, and Completion/Summary Reports approvals as per the compliance requirements
• Validated experience as Quality Contact for complex projects involving packaging, inspection, and new products
• Validated experience in Commissioning and Qualification
• Strong organizational skills, including ability to follow assignments through to completion
• Enhanced skills in leading, influencing and negotiating
• Demonstrate ability to interact with regulatory agencies
• Solid word processing, presentation, database and spreadsheet application skills
• Strong communication (both written and oral), facilitation and presentation skills
• Proven skill in working independently and to effectively interact with all levels throughout the organization
• Advanced data trending and evaluation
• Ability to evaluate compliance issues.

EDUCATION/EXPERIENCE

Doctorate degree or Master's degree and 2 years of directly related experience or Bachelor's degree and 4 years of directly related experience or Associate's degree and 10 years of directly related experience or High school diploma / GED and 12 years of directly related experience

Skills and competencies:
-Project management skills.
- Strong organizational skills, including ability to follow assignments through to completion.
- Initiate and lead cross functional teams.
- Enhanced skills in leading, influencing and negotiating.
- Strong knowledge in area of expertise.
- Collaborate and coordinate with higher level outside resources.
- Strong knowledge of and experience with processes involved in manufacturing and distribution, QA, QAL, validation and process development.
- Demonstrate ability to interact with regulatory agencies.
- Strong word processing, presentation, database and spreadsheet application skills.
- Strong communication (both written and oral), facilitation and presentation skills.
- Strong skill in working independently and to effectively interact with various levels.
- Advanced data trending and evaluation.
- Ability to evaluate compliance issues.

PharmaLex is an Equal Opportunity Employer.
from 25.00PH 
Shifts - Non-Standard
Contract - 4 months 

We are an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, creed, national origin, ancestry, sex, age, handicap or disability, marital status, sexual orientation, gender identity or expression, pregnancy or pregnancy-related condition, genetic information, veteran status, immigration or citizenship status, military obligations, status as a domestic violence victim or a victim of sexual assault or stalking, participation in discrimination complaint-related activities, or any other status protected under applicable federal, state or local law.

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