Specialist - Quality Assurance - Pharmaceutical/Biotechnology/Clinical Research

Quality Assurance Specialist - Pharmaceuticals/Biotechnology/Clinical Research (10-15 yrs)

- QA/QC - Pharma/Healthcare

- Quality Assurance

- Quality Control

- Quality Audit

- Quality Assurance Head

- Quality Control Head

- Project Management - Pharma/Healthcare

Location: Overseas/International/US/New York

Experience: 10 - 15 Years

Annual Salary : $75,000.00-$100,000.00 USD

Work Location: Central Islip, New York, USA

Domain : Pharmaceuticals/Biotechnology/Clinical Research

- The purpose of this position is to serve as a Quality Assurance (QA) Leader/Specialist role supporting the Chemistry & Manufacturing Services (CMS) Integrated Projects Team. 

- This role will report to the Head of Quality for North America or other Department Head/senior leader in the Quality organization. Depending on the education, training, experience or a combination of qualifications and background of the selected candidate, this role may be modified and classified as a Specialist or Section Head. The role can be described as a - coach- as it is hands-on and executed - on the shop floor or in the laboratory.

- This role will have the primary focus of providing project management and oversight of the third parties and/or remotely operating QA groups. The scope of this focus will include but not limited to:

- Directing the activities and team members of remote QA groups.

- Accountable for the oversight of the work plan and deliverables of remote QA groups.

- Accountable for special projects and initiatives as directed.

- This role will be part of the Quality Control (QC)/Analytical QA Team whose role is to ensure our patients receive the medicine of the highest quality. We accept the trust patients place in us and we deliver quality medicines.

The general duties and responsibilities of this role include but are not limited to the following :

- Setting work plans and schedules to align with business priorities.

- The direction of work on an individual or group basis, as required.

- Oversee cGMP compliance.

- Review the work of the department.

- Conduct troubleshooting or investigation activities in a group setting.

- Ensuring that tools are provided, and concerns are escalated, as appropriate.

- Ensure that the department teams are working in a safe way and following all safety rules and procedures.

- Ensure compliance with all data integrity and cGMP practices, procedures, and expectations.

- Other specific duties and responsibilities as assigned.

QUALIFICATIONS :

The ideal candidate minimum qualifications will include :

- A Bachelor's degree (BS or BA) in Chemistry or related technical/physical science from an accredited college/university is required. A master's degree in a field to study relevant to the position is preferred.

- Not less than (NLT) ten (10) years of relevant experience in QA Operations.

- Experience working in pharmaceutical manufacturing is preferred.

- Solid project management skills and experience are required.

- NLT three (3) years of relevant experience directing work in a group setting.

- Proficiently speak English as a first or second language.

- Proficiently communicate and understand (read and write) scientific/regulatory based - work- in English.

- Bi-lingual in the Spanish language (speaking, writing, interoperating and translation) is preferred.

- Have excellent organization, learning and teaching skills required to work in teams.

- Ability to understand and analyze complex data sets.

- Strong desire for continuous improvement.

- Know how to use Microsoft Office programs and other scientific-based software.

WORKING CONDITIONS AND EXPECTATIONS :

- This role works in a current Good Manufacturing Practice (cGMP) office, laboratory and manufacturing environment, where personal protective equipment (PPE) may be required, which may include uniforms, lab coats, safety glasses, respiratory PPE, hearing protection, etc.

- Work with or around solvents, powders, or other materials commonly found in a pharmaceutical laboratory or manufacturing facility may be required.

- Sitting at a desk and/or working at a computer or other - screen- 75% or greater of an 8-hour period may be required.

OTHER JOB INFORMATION :

- The relocation was negotiable.

- No employment sponsorship.

- No remote work available.

- Must be willing to work long hours and some weekends based on a relevant business need, if required.

SOURCING GUIDELINES: 

For the Senior QA Specialist? Third-Party Projects:

- Must have a solid working background in chemistry/QC lab.

- Direct experience working in GMP pharmaceutical manufacturing.

- Strong project management skills.

- Experience managing and interfacing with external vendors, CMOS, etc.

- Possess effective business communications (verbal and written) skills and working proficiency and command of the English language.

- Demonstrated ability to operate across multiple levels of personnel.

- No employment sponsorship.

Should be HB1/ Green Card Holder or US Citizen