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Company: Sever Pharma Solutions
Location: Putnam
Posted on: January 27, 2023

Job Description:

SUMMARY Reporting to the QA Supervisor, the Quality Assurance Specialist position maintains a quality presence which supports all activities of cGMP regarding pharmaceutical manufacturing, testing and release to ensure compliance with all relevant pharmaceutical regulatory requirements: FDA, GMP. Provides QA oversight to Operations and Analytical Laboratory under direction of the Supervisor, Quality Assurance. Provides review, impact/risk assessment analysis, detailed improvement plans for all aspects of the Quality Systems including but not limited to change controls, investigations, deviations, complaint handling, and CAPA. Adheres to Foster Delivery Science's compliance initiatives, including following all quality and company policy requirements. The Quality Assurance Specialist independently conducts quality assurance audits of production/test records (manufacturing, analytical / quality control records) and facility records assuring company standards are maintained and product integrity is preserved. ESSENTIAL DUTIES AND RESPONSIBILITIES

  • Implements and maintains quality systems, policies and procedures that ensure compliance to cGMP, FDA (i.e. 21CFR11, 820, 210, 211) and other regulatory standards.
  • Performs complex manufacturing batch production record reviews and approval in support of product release in accordance with specifications and procedures.
  • Performs complex test record data reviews and approval in support of stability testing and laboratory testing in accordance with specifications and procedures.
  • Provide support to GMP investigations (including Out-of-Specification),validation documentation review and approval, identify gaps within existing Quality Systems and propose solutions for functional management.
  • Participates/leads internal/external audits, prepare and issue audit reports. Recommend remediation actions and follow up on implementation of the plan.
    • Supports resolution of technical and compliance issues/gap analysis.
    • Aides implementation of Quality Systems/System Improvements.
    • Supports and assists with Quality systems-related training, including compliance with cGMP and SOPs.
    • Interface with key quality, manufacturing personnel, and customers to coordinate documentation impacting quality areas.
    • Review/approval of all cGMP documents generated across site to include (but not limited to): SOPs, technical reports, validation documents, QA assessment, APQRs, audit documents, change control, deviation & document revisions, etc---
      • Participates and/or leads meetings, associated with primary batch record review and batch release, non-conformances investigation and CAPA.
      • Work in coordination with regulatory affairs group in support of regulatory submissions.
      • Participates in FDA inspections and customer audits, as required.
      • Provides QA review/approval of all cGMP documents associated with manufacture of product.
      • Communicates with contractors, laboratory personnel and internal manufacturing/technical groups regarding compliance and quality issues (i.e., batch documentation, OOS, Stability, timelines and data related issues).
        • Authors or revises SOPs as necessary.
        • Actively engaged in the training of staff with lesser experience or knowledge of quality assurance processes. Educate and instruct QA and plant personnel in quality best practices for sampling, labeling, good documentation practices, equipment sanitation. Confirm these procedures are being adhered to, taking corrective actions when non-conformances are observed.
        • Routinely provide input to quality and operations management for better operational procedures to improve overall efficiency and regulatory compliance.
        • Assist in development of special department projects and work in conjunction with quality management.
        • Other duties as assigned by Supervisor, Quality Assurance. SUPERVISORY RESPONSIBILITY
          • This position has no direct supervisory responsibilities but does assist with training of staff of lesser experience in the group.
          • This position may provide leadership to teams or groups formed for specific objectives. QUALIFICATIONS
            • Strong background and demonstrated effectiveness in quality assurance operation and compliance of commercial medical device / pharmaceutical in an FDA regulated environment.
            • Knowledge of Analytical Laboratory processes, data review and Laboratory systems.
            • Knowledge of plastics manufacturing, analytical testing is highly desirable.
            • Extensive knowledge of FDA and EU cGMP regulations
              • Knowledge of pharmaceutical and finished product manufacturing, analytical testing is desirable.
              • Knowledge of electronic manufacturing support systems including any of the following: EMS and QMS desirable
              • Experience with FDA Preapproval Inspection preparation and management is essential.
              • Demonstrated leadership, interpersonal, communication, and motivation skills.
              • Familiarity with the tools, concepts and methodologies of Quality Management Systems.
                • Strong analytical, problem solving, and decision-making skills (i.e. DMAIC, FMEA, DOE, SPC, Lean)
                • Attention to detail is crucial in this position.
                • Able to work closely with all other departments within Foster Delivery Science
                • Able to work closely with all customers and suppliers.
                • Flexible in handling multiple and changing work assignments daily.
                  • Self-reliant in meeting goals and objectives
                  • Ability to effectively present information and respond to questions from groups of managers and customers. EDUCATION AND/OR EXPERIENCE
                    • Knowledge of science generally attained through studies resulting in a B.S., or higher, in science, engineering, biochemistry or related discipline, or its equivalent is preferred.
                      • Experience in medical device / pharmaceutical regulated environment with an at least 2 years focused on Quality Assurance / Systems.
                      • Working knowledge of FDA/EU regulatory requirements applicable to pharmaceutical drug products. Ability to apply cGMP regulations to all aspects of the position.
                      • Experience executing Change Control, Risk/Impact assessment, Deviation / EM excursion investigations, OOS/OOT and CAPA. Cleaning / process validation experience and demonstrated ability to make key decisions.
                      • Strong working knowledge of Microsoft Office products. Technical writing experience.
                      • Familiarity with electronic Quality Management Systems.
                        • Strong knowledge of current Good Manufacturing Practices and Good Documentation Practices, Part 11 requirements, familiarity with process and cleaning validation, equipment qualification, validation of computerized systems and ISO cleanroom standards. LANGUAGE SKILLS
                          • Ability to read and interpret documents such as safety rules, operating and maintenance instructions, and procedure manuals.
                          • Ability to write detailed procedures and work instructions.
                            • Ability to speak effectively before groups of customers or employees of the organization. MATHEMATICAL SKILLS
                              • Ability to work with mathematical concepts and fundamentals of applied statistics.
                              • Ability to apply concepts such as fractions, percentages, ratios, and proportions to practical situations. REASONING ABILITY Exercises judgment within generally defined practices and policies in selecting methods and techniques for obtaining solutions. Makes sound decisions and applies appropriate notification to management as appropriate. Ability to deal with problems involving several concrete variables in standardized situations. CERTIFICATES, LICENSES, REGISTRATIONS Certificate in Process Improvement and/or Lean - Highly desirable ISPE, ASQ (American Society for Quality) and/or ISO certification as an Auditor or Quality Improvement Associate - desirable PHYSICAL DEMANDS Physical demands of this job are minimal. The employee must occasionally lift and/or move up to 30 pounds. Working with proper PPE and gowning for cGMP Cleanrooms and Analytical Laboratories is required. WORK ENVIRONMENT Work is largely performed in an office environment, laboratory, and manufacturing facility where one must be aware of the presence of workplace standards including machinery and testing equipment. Use of protective gowning for the Clean Room areas and personal protective equipment (PPE) will be required in some portions of the facility.


Keywords: Sever Pharma Solutions, New England , QUALITY ASSURANCE SPECIALIST, Other , Putnam, Northeast

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