UNKNOWN

FEED

Provide support to GMP investigations, validation documentation review and approval, identify gaps within existing Quality Systems and propose solutions for functional management; 2. Participates/leads internal/external audits, prepare and issue audit reports. Review/approval of all cGMP documents generated across site to include (but not limited to): SOPs, technical reports, validation documents, QA assessment, APRs, audit documents, change control, deviation & document revisions, etc.

SUMMARY/OBJECTIVE This position supports activities of the Quality Assurance Department regarding pharmaceutical manufacturing, testing and packaging to ensure compliance with all relevant pharmaceutical regulatory requirements: FDA, GMP. Provides QA oversight to operations under direction of the QA Manager. Provides review, impact/risk assessment analysis, detailed improvement plans for change controls, deviations, investigations and CAPA. Adheres to Client compliance initiatives, including following all quality and division/company policy requirements. Helps to ensure that all Client products meet quality requirements by supporting all assigned quality aspects of product approval. The QA Associate II/III independently conducts quality assurance audits of production records (manufacturing, analytical and quality control records) and facility records assuring company standards are maintained and product integrity is preserved. RESPONSIBILITIES 1. Provide support to GMP investigations, validation documentation review and approval, identify gaps within existing Quality Systems and propose solutions for functional management; 2. Participates/leads internal/external audits, prepare and issue audit reports. Recommend remediation actions and follow up on implementation of the plan. 3. Supports resolution of technical and compliance issues/gap analysis. 4. Aides implementation of Quality Systems/System Improvements. 5. Supports and assists with Quality systems-related training, including compliance with cGMP and SOPs. 6. Interface with key quality, manufacturing, customers and coordinate documentation impacting quality areas. 7. Review/approval of all cGMP documents generated across site to include (but not limited to): SOPs, technical reports, validation documents, QA assessment, APRs, audit documents, change control, deviation & document revisions, etc. 8. Participates in activities associated with primary batch record review, non-conformances investigation and CAPA. 9. Work in coordination with regulatory affairs group in support of ANDA submissions. 10. Provides QA review/approval of all cGMP documents associated with manufacture of product. 11. Communicates with contractors and internal manufacturing/technical groups regarding compliance and quality issues (i.e., batch documentation, investigations, timelines and data related issues). 12. Authors or revises SOPs as necessary. 13. 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. 14. Routinely provide input to quality and operations management for better operational procedures to improve overall efficiency and regulatory compliance. 15. Assist in development of special department projects and work in conjunction with quality management. 16. Other duties as assigned. COMPETENCIES 1. Project Management 2. Technical Capacity. 3. Discretion. 4. Problem Solving/Analysis. 5. Decision Making. 6. Communication Proficiency. 7. Collaboration Skills. 8. Learning Agility 9. Managing Changing Priorities POSITION TYPE/EXPECTED HOURS OF WORK This is a full-time position requiring 40 or more hours of work per week.

CEDENT

Quality Assurance Associate I

Abbreviated New Drug Application

Analysis Skills

Auditing

Best Practices

Biotech and Pharmaceutical

Change Control

Corporate Policies

Corrective Action

Corrective and Preventative Action (CAPA) Systems

Current Good Manufacturing Practice (cGMP)

Documentation

Documentation Review

Drug Manufacturing

External Audit

FDA Requirements

GMP (Good Manufacturing Practices)

Gap Analysis

Internal Audit

Maintain Compliance

Manufacturing

Manufacturing Analysis

Operational Improvement

Operations Management

Operations Processes

Problem Solving Skills

Project Development

Project/Program Management

Quality Assurance

Quality Assurance Methodology

Quality Control

Quality Management

Regulations

Regulatory Compliance

Risk Analysis

Staff Training

Standard Operating Procedures (SOP)

Team Player

Technical Support

Testing

Validation Documentation

The Applicant Manager

Compensation ranges for ASM Research positions vary depending on multiple factors; including but not limited to, location, skill set, level of education, certifications, client requirements, contract-specific affordability, government clearance and investigation level, and years of experience. The physical requirements described in "Knowledge, Skills and Abilities" above are representative of those which must be met by an employee to successfully perform the primary functions of this job.

The Quality Assurance (QA) Specialist is responsible for analyzing the efficiency and effectiveness of individual case analysts.Key Responsibilities:The Quality Assurance (QA) Specialist is responsible for analyzing the efficiency and effectiveness of individual case analysts. To accomplish this, the QA Specialist reviews cases, emails, and recorded telephonic interactions and evaluates them for compliance to standardized process requirements. Requirements involve confirming that activity efforts align with casework expectations and outcome. Activities may include discerning soft skills in phone calls and clear communication in emails. Based on the review, the Quality Analyst provides a concise written analysis of the work reviewed along with feedback and coaching recommendations to improve the performance of the program.Required minimum qualifications:<ul><li>Bachelor's Degree or equivalent OR 4 years of relevant experience in lieu of degree.</li><li>Experience following defined processes.</li><li>Must be a US Citizen</li></ul>Candidates that do not meet the required qualifications will not be consideredPreferred qualifications:<ul><li>Experience with CMS's 1095-A</li><li>Advanced proficiency with MS Office including SharePoint, Teams, Excel, Word, and PowerPoint</li><li>Strong verbal and written communication skills</li><li>Familiarity with process improvement systems such as Lean Six Sigma, Agile, and others.</li><li>Experience providing data that supports project decision</li><li>Previous Federal Government experience.</li></ul>Compensation RangesCompensation ranges for ASM Research positions vary depending on multiple factors; including but not limited to, location, skill set, level of education, certifications, client requirements, contract-specific affordability, government clearance and investigation level, and years of experience. The compensation displayed for this role is a general guideline based on these factors and is unique to each role. Monetary compensation is one component of ASM's overall compensation and benefits package for employees.EEO RequirementsIt is the policy of ASM that an individual's race, color, religion, sex, disability, age, sexual orientation or national origin are not and will not be considered in any personnel or management decisions. We affirm our commitment to these fundamental policies.All recruiting, hiring, training, and promoting for all job classifications is done without regard to race, color, religion, sex, disability, or age. All decisions on employment are made to abide by the principle of equal employment.Physical RequirementsThe physical requirements described in "Knowledge, Skills and Abilities" above are representative of those which must be met by an employee to successfully perform the primary functions of this job. (For example, "light office duties' or "lifting up to 50 pounds" or "some travel" required.) Reasonable accommodations may be made to enable individuals with qualifying disabilities, who are otherwise qualified, to perform the primary functions.DisclaimerThe preceding job description has been designed to indicate the general nature and level of work performed by employees within this classification. It is not designed to contain or be interpreted as a comprehensive inventory of all duties, responsibilities and qualifications required of employees assigned to this job.18.00 - 20.00EEO RequirementsIt is the policy of ASM that an individual's race, color, religion, sex, disability, age, gender identity, veteran status, sexual orientation or national origin are not and will not be considered in any personnel or management decisions. We affirm our commitment to these fundamental policies.All recruiting, hiring, training, and promoting for all job classifications is done without regard to race, color, religion, sex, veteran status, disability, gender identity, or age. All decisions on employment are made to abide by the principle of equal employment.

ASM Research, An Accenture Federal Services Company

ENHD Quality Assurance Specialist

Administrative Skills

Agile Programming Methodologies

Coaching

Communication Skills

Contract Requirements

Decision Support

Lean Six Sigma

Lift/Move 50 Pounds

Microsoft Excel

Microsoft Office

Microsoft PowerPoint

Microsoft SharePoint

Microsoft Word

Performance Management

Physical Demands

Presentation/Verbal Skills

Process Improvement

Security Clearance

Telephone Skills

United States Citizen

Willing to Travel

Writing Skills

IRecruitee

Interested applicants must follow the directions in the "How to Apply" section of this flyer to be considered. This is a public notice flyer to notify interested applicants of anticipated vacancies.

<h5>Quality Assurance Specialist (Shipbldg) </h5>This is a public notice flyer to notify interested applicants of anticipated vacancies. Applications will not be accepted through this flyer. Interested applicants must follow the directions in the "How to Apply" section of this flyer to be considered. There may or may not be actual vacancies filled from this flyer. Notice of Result letters will not be sent to applicants who respond to this flyer.

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Quality Assurance Associate I CEDENT

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