Quality Assurance Product Specialist in Albuquerque, NM at AMRI

Date Posted: 7/21/2019

Job Snapshot

Job Description

Quality Assurance Product Specialist (QAPS)
Albany Molecular Research Inc. provides global contract research and manufacturing services to the pharmaceutical and biotechnology industries. 
Summary AMRI specializes in contract manufacturing of liquid and lyophilized small volume parenteral products using aseptic processing technology, to deliver high quality sterile products to the pharmaceutical industry.  AMRI offers value added services to assist customers in the development and manufacture of a variety of sterile products. The Quality Assurance Department is responsible to implementing all procedures leading to compliant, valid, and documented release of drug, biologic product, or medical device by performing the following duties personally or through subordinate specialists.
Customers range from mid-tier companies, biotechnical, biological and virtual pharmaceutical development organizations to large billion dollar multinational pharmaceutical corporations.   Product manufacturing includes the developmental cycle for injectable drugs from NDA & ANDAs, new formulations, drugs in clinical trials, stability studies and commercial products in the generic, prescription and OTC markets.
The AMRI Quality Assurance (QA) department is responsible for directing the development, implementation and maintenance of quality assurance standards, methods and procedures, as well as, quality control systems to ensure the precision, accuracy and reliability of company services in accordance with quality specifications, FDA requirements and cGMP standards for AMRI.
 
 
Essential Duties and Responsibilities include the following. Other duties may be assigned.
Acts as the primary Quality Assurance contact for clients, AMRI Service Department, and AMRI Technical Project Management department.
Responsible for Batch Record review and release of product (Manufacturing and Packaging),
Responsible for participating in major investigations related to product lots.
Responsible for investigating customer complaints.
Recommends and/or enacts changes to all applicable SOP’s.  
Effectively coordinates functions of internal QA organization with client and necessary AMRI departments. 
Effectively communicates within company and internal departments, outside vendors and professional organizations.
Interfaces with the other AMRI Departments and Customer Service department as needed to communicate and maintain a partnership necessary for third-party manufacturing operations and ensure highest quality standards and regulatory compliance.
Responsible for establishing and maintaining systems and procedures to ensure compliance of AMRI with all applicable regulations.
Coordinates key systems including Change Control, Batch Records (Manufacturing and Packaging) and other functions impacting the Quality area and related to assigned products and clients.
Supports AMRI Compliance department during FDA and other agency inspections as well as customer and internal audits. 
Makes formal presentations within the company, to customers at site wide meetings and on-site wide projects. 
Interfaces with all other departments to ensure coordination and compliance with SOPs and cGMPs. 
Provides all additional Quality Assurance support and functions as specified by the Director of Quality Assurance.
Cross-trained in duties and functions of a Manufacturing Quality Assurance Manager. 
Review of Annual Product Review (APR) for customer related products.
Ability to work in a timely manner and under pressure to meet customer and business deadlines associated with batch record lot release.
Supervisory Responsibilities                                                   
 
This job has no supervisory responsibilities.

Job Requirements

Competencies                                                  
 
To perform the job successfully, an individual should demonstrate the following competencies:
 
Analytical - Synthesizes complex or diverse information; Collects and researches data; Uses intuition and experience to complement data; Designs work flows and procedures.
Design - Generates creative solutions; Translates concepts and information into images; Uses feedback to modify designs; Applies design principles; Demonstrates attention to detail.
Problem Solving - Identifies and resolves problems in a timely manner; Gathers and analyzes information skillfully; Develops alternative solutions; Works well in group problem solving situations; Uses reason even when dealing with emotional topics.
Project Management - Develops project plans; Coordinates projects; Communicates changes and progress; Completes projects on time and budget; Manages project team activities.
Technical Skills - Assesses own strengths and weaknesses; Pursues training and development opportunities; Strives to continuously build knowledge and skills; Shares expertise with others.
Customer Service - Manages difficult or emotional customer situations; Responds promptly to customer needs; Solicits customer feedback to improve service; Responds to requests for service and assistance; Meets commitments.
Interpersonal Skills - Focuses on solving conflict, not blaming; Maintains confidentiality; Listens to others without interrupting; Keeps emotions under control; Remains open to others' ideas and tries new things.
Oral Communication - Speaks clearly and persuasively in positive or negative situations; listens and gets clarification; Responds well to questions; Demonstrates group presentation skills; Participates in meetings.
Written Communication - Writes clearly and informatively; Edits work for spelling and grammar; Varies writing style to meet needs; Presents numerical data effectively; Able to read and interpret written information.
Teamwork - Balances team and individual responsibilities; Exhibits objectivity and openness to others' views; Gives and welcomes feedback; Contributes to building a positive team spirit; Puts success of team above own interests; Able to build morale and group commitments to goals and objectives; Supports everyone's efforts to succeed.
Visionary Leadership - Displays passion and optimism; Inspires respect and trust; mobilizes others to fulfill the vision; Provides vision and inspiration to peers and subordinates.
Change Management - Develops workable implementation plans; Communicates changes effectively; Builds commitment and overcomes resistance; Prepares and supports those affected by change; Monitors transition and evaluates results.
Delegation - Delegates work assignments; Matches the responsibility to the person; Gives authority to work independently; Sets expectations and monitors delegated activities; Provides recognition for results.
Leadership - Exhibits confidence in self and others; Inspires and motivates others to perform well; effectively influences actions and opinions of others; Accepts feedback from others; Gives appropriate recognition to others.
Quality Management - Looks for ways to improve and promote quality; Demonstrates accuracy and thoroughness.
Business Acumen - Understands business implications of decisions; Displays orientation to profitability; Demonstrates knowledge of market and competition; Aligns work with strategic goals.
Cost Consciousness - Works within approved budget; Develops and implements cost saving measures; Contributes to profits and revenue; Conserves organizational resources.
Diversity - Demonstrates knowledge of EEO policy; Shows respect and sensitivity for cultural differences; educates others on the value of diversity; promotes a harassment-free environment; Builds a diverse workforce.
Ethics - Treats people with respect; Keeps commitments; inspires the trust of others; Works with integrity and ethically; Upholds organizational values.
Organizational Support - Follows policies and procedures; Completes administrative tasks correctly and on time; supports organization's goals and values; Benefits organization through outside activities; Supports affirmative action and respects diversity.
Strategic Thinking - Develops strategies to achieve organizational goals; Understands organization's strengths & weaknesses; Analyzes market and competition; Identifies external threats and opportunities; Adapts strategy to changing conditions.
Judgment - Displays willingness to make decisions; Exhibits sound and accurate judgment; Supports and explains reasoning for decisions; Includes appropriate people in decision-making process; Makes timely decisions.
Motivation - Sets and achieves challenging goals; Demonstrates persistence and overcomes obstacles; Measures self against standard of excellence; Takes calculated risks to accomplish goals.
Planning/Organizing - Prioritizes and plans work activities; Uses time efficiently; Plans for additional resources; Sets goals and objectives; Organizes or schedules other people and their tasks; Develops realistic action plans.
Professionalism - Approaches others in a tactful manner; Reacts well under pressure; Treats others with respect and consideration regardless of their status or position; Accepts responsibility for own actions; Follows through on commitments.
Quality - Demonstrates accuracy and thoroughness; Looks for ways to improve and promote quality; Applies feedback to improve performance; Monitors own work to ensure quality.
Quantity - Meets productivity standards; Completes work in timely manner; Strives to increase productivity; Works quickly.
Safety and Security - Observes safety and security procedures; Determines appropriate action beyond guidelines; Reports potentially unsafe conditions; Uses equipment and materials properly.
Adaptability - Adapts to changes in the work environment; Manages competing demands; Changes approach or method to best fit the situation; Able to deal with frequent change, delays, or unexpected events.
Attendance/Punctuality - Is consistently at work and on time; Ensures work responsibilities are covered when absent; Arrives at meetings and appointments on time.
Dependability - Follows instructions, responds to management direction; Takes responsibility for own actions; Keeps commitments; Commits to long hours of work when necessary to reach goals. Completes tasks on time or notifies appropriate person with an alternate plan.
Initiative - Volunteers readily; Undertakes self-development activities; Seeks increased responsibilities; Takes independent actions and calculated risks; Looks for and takes advantage of opportunities; Asks for and offers help when needed.
Innovation - Displays original thinking and creativity; Meets challenges with resourcefulness; Generates suggestions for improving work; Develops innovative approaches and ideas; Presents ideas and information in a manner that gets others' attention.
 
Qualifications To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
 
Education and/or Experience                                                  
 
Bachelor’s Degree in Science, Chemistry, or Biology.  Five (5) years of experience in quality assurance and/or regulatory experience in the Pharmaceutical industry, OR ten (10) years of experience in Pharmaceutical industry with demonstrated understanding of laboratory, manufacturing, packaging, regulatory, compliance, and quality assurance requirements for biological and drug product manufacturing.  Must have knowledge of the US, European and Japanese Compendia requirements for a pharmaceutical facility and an analytical/microbiological laboratory.  
 
Language Skills                                              
 
Ability to read, analyze, and interpret common scientific and technical journals, financial reports, and legal documents.  Ability to respond to common inquiries or complaints from customers, regulatory agencies, or members of the business community.  Ability to write speeches and articles for publication that conform to prescribed style and format.  Ability to effectively present information to top management, public groups, and/or boards of directors.
 
 
Mathematical Skills                                                    
 
Ability to work with mathematical concepts such as probability and statistical inference, and fundamentals of plane and solid geometry and trigonometry.  Ability to apply concepts such as fractions, percentages, ratios, and proportions to practical situations.
 
 
Reasoning Ability                                           
 
Ability to define problems, collect data, establish facts, and draw valid conclusions. Ability to interpret an extensive variety of technical instructions in mathematical or diagram form and deal with several abstract and concrete variables.
 
Computer Skills                                              
 
To perform this job successfully, an individual should have knowledge of Spreadsheet software and Word Processing software.
  
Other Skills and Abilities   
Provides leadership in coordinating audits and services as the resident QA product expert at site and among departmental staff.  Must have demonstrated ability to work independently and as a team leader.  Must show innovative development techniques and strategic thinking abilities. Capable of review and audit analyses following written procedures for projects not based on written procedures like Chemistry method development or validation. Able to organize and write complex technical documents. Ability to write clear, concise, complex reports, assessments and documents.
Extensive knowledge of cGMP, EU and other country regulations involved in the technical development and manufacturing processes of pharmaceutical drug products.  Knowledge of quality, regulatory and legal standards including USP, EP, JP, GLP, GMP, EPA, OSHA, ICH, DEA and FDA.  Knowledge of Quality Systems as they related to SOP creation and control, Validation of Computerized Systems per Code of Federal Regulations, Chapter 21, Part 11.
 
Familiar with GUI (Graphic User Interface) such as Windows. Familiar with laboratory Microsoft Word and Excel computer programs.  Must also have extensive working knowledge of Trackwise and Oracle ERP system. 
 
Physical Demands The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
 
While performing the duties of this Job, the employee is regularly required to sit and talk or hear. The employee is frequently required to walk; use hands to finger, handle, or feel and reach with hands and arms. The employee is occasionally required to stand and stoop, kneel, crouch, or crawl. The employee must regularly lift and /or move up to 25 pounds, frequently lift and/or move up to 10 pounds.  Specific vision abilities required by this job include close vision, distance vision, color vision, peripheral vision, depth perception and ability to adjust focus. 
 
Work Environment The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
 
While performing the duties of this Job, the employee is frequently exposed to moving mechanical parts. The employee is occasionally exposed to high, precarious places; fumes or airborne particles and toxic or caustic chemicals. The noise level in the work environment is usually moderate.

Shift:  Standard 8

Albany Molecular Research, Inc. is committed to providing equal opportunity to all job seekers including qualified individuals with disabilities. If you have any difficulty using our online application system due to a disability or believe you need a reasonable accommodation to search for a job opening or submit an application, you may use the alternative email address "jobs@amriglobal.com" to contact us about your interest in employment or you may call us at 518.512.2000.

Please note: The above-referred email address and telephone number are dedicated communication lines designed exclusively to assist job seekers whose disability prevents them from being able to apply online. Messages left for other purposes will not receive a response.

AMRI is committed to providing equal opportunity to all job seekers including qualified individuals with disabilities. If you have any difficulty using our online application system due to a disability or believe you need a reasonable accommodation to search for a job opening or submit an application, you may use the alternative email address jobs@amriglobal.com to contact us about your interest in employment or you may call us at 518.512.2000.

Please note: The above referenced email address and telephone number are dedicated communication lines designed exclusively to assist job seekers whose disability prevents them from being able to apply online. Messages left for other purposes will not receive a response.