Senior QA Specialist- Consultant

AmerisourceBergen; United States; Remote; USD 60,000 - 100,000; Full time

Job summary

An innovative company is seeking a dedicated Quality Assurance professional to join their team. This role is central to maintaining compliance and ensuring the quality of drug products. The successful candidate will be responsible for managing quality documents, conducting audits, and supporting product release activities. With a focus on collaboration and communication, you will work closely with clients and internal teams to uphold the highest standards of quality. If you are passionate about making a difference in the healthcare sector and thrive in a dynamic environment, this opportunity is for you.

Benefits

Medical, dental, and vision care

Paid parental leave

Professional development resources

Mentorship programs

Backup dependent care

Adoption assistance

Infertility coverage

Qualifications

• 5+ years of experience in Quality Assurance with a Bachelor's degree in a related field.
• Regulatory Affairs certification is a plus, along with vendor audit experience.

Responsibilities

• Maintain Drug Establishment Licenses and ensure compliance with GMP regulations.
• Review and assess quality documents and support during audits and inspections.

Skills

Quality Assurance

Regulatory Compliance

Data Analysis

Project Management

Attention to Detail

Communication Skills

Education

Bachelor’s degree in a pharmaceutical or healthcare related field

Tools

MS Office Suite

eQMS

CRM

Job description

Our team members are at the heart of everything we do. At Cencora, we are united in our responsibility to create healthier futures, and every person here is essential to us being able to deliver on that purpose. If you want to make a difference at the center of health, come join our innovative company and help us improve the lives of people and animals everywhere. Apply today!

Job Details

Primary Duties and Responsibilities:

• Maintenance of importer Drug Establishment Licenses (DELs) and the approval process for a large number of foreign sites for multiple clients.
• Coordinate with clients and/or foreign sites for the receipt, review and updates to master documents to ensure compliance to GMPs and in relation to product release activities.
• Release of commercial drug product and/or clinical trial supply to the Canadian market for Innomar or customers as required.
• Perform timely review and assessment of documents received from clients/foreign sites, including but not limited to manufacturing and packaging records, Certificates of Analysis, Certificates of Manufacture, and other product release documents.
• Assist Management in the preparation of routine key quality performance indicators (KPIs) to generate client specific report metrics, acting as a Team Lead when required.
• Maintain and review in-house and client-based quality documents, e.g. SOPs, APQR, stability reports, qualification/validation protocols and reports, artwork, temperature studies etc.
• Process Deviation investigations, including report generation and any associated trend analysis.
• Process Product Quality Complaints (PQCs), including report generation and any associated trend analysis.
• Process Change Control Requests (CCRs), including report generation and any associated trend analysis.
• Assist QA Management in the development/revision and implementation of QA policies and procedures, acting as a Team Lead when required.
• Sustain an effective system for maintaining copies of documents received from clients/foreign sites as well as those submitted to Health Canada, allowing ease of location and retrieval of records.
• Provide support during audits/inspections (i.e. internal, client, third party or regulatory agencies) as required.
• Provide support during recall/mock recall events (client and internal) as required, acting as a Team Lead when required.
• Build and maintain a positive and productive liaison with internal and external contacts, including interfacing with potential clients.
• Participate in and support project teams and advise other departments on Quality Assurance issues and strategies, when required.
• Travel up to 20% may be required.
• Other duties, as assigned.

Experience and Educational Requirements:

• Bachelor’s degree in a pharmaceutical or healthcare related field (e.g. chemistry, biology, microbiology, pharmacy, and pharmacology).
• Minimum of 5 years’ experience in Quality Assurance.
• Regulatory Affairs or Quality Assurance Certification is considered an asset.
• Experience in conducting vendor audits is considered an asset.
• Experience in hosting/co-hosting client audits is considered an asset.
• Experience working in an Operations environment is considered an asset.

Minimum Skills, Knowledge and Ability Requirements:

• Comprehensive knowledge of the Food and Drugs Act, Health Canada GMP regulations and associated guidelines.
• Demonstrated ability to effectively prioritize, coordinate and complete multiple projects within established timeframes.
• Demonstrated ability in the effective management of deviations, root cause analysis, and CAPA implementation.
• The ability to identify pragmatic solutions to compliance/operational problems and challenges.
• Strong attention to detail, proven data analysis skills and the ability to present these findings effectively.
• Ability to work both independently and in a team environment, always promoting positive, respectful and professional relationships.
• Strong proficiency in common office applications (e.g. MS Word, Excel, PowerPoint, Outlook, Adobe Acrobat, etc.) and the ability to achieve rapid fluency in business related electronic applications/platforms (e.g., eQMS, EMS, WMS, CRM, etc.).
• Excellent written and verbal communication skills.

The successful candidate will (requirement)/may (asset) have daily contacts with unilingual English-speaking customers, patients or peers from cross-functional teams.

What Cencora offers

We provide compensation, benefits, and resources that enable a highly inclusive culture and support our team members’ ability to live with purpose every day. In addition to traditional offerings like medical, dental, and vision care, we also provide a comprehensive suite of benefits that focus on the physical, emotional, financial, and social aspects of wellness. This encompasses support for working families, which may include backup dependent care, adoption assistance, infertility coverage, family building support, behavioral health solutions, paid parental leave, and paid caregiver leave. To encourage your personal growth, we also offer a variety of training programs, professional development resources, and opportunities to participate in mentorship programs, employee resource groups, volunteer activities, and much more.

Full time

Equal Employment Opportunity

Cencora is committed to providing equal employment opportunity without regard to race, color, religion, sex, sexual orientation, gender identity, genetic information, national origin, age, disability, veteran status or membership in any other class protected by federal, state or local law.

The company’s continued success depends on the full and effective utilization of qualified individuals. Therefore, harassment is prohibited and all matters related to recruiting, training, compensation, benefits, promotions and transfers comply with equal opportunity principles and are non-discriminatory.

Cencora is committed to providing reasonable accommodations to individuals with disabilities during the employment process which are consistent with legal requirements. If you wish to request an accommodation while seeking employment, please call 888.692.2272 or email [e-mail]. We will make accommodation determinations on a request-by-request basis. Messages and emails regarding anything other than accommodations requests will not be returned.

Accessibility Policy

Cencora is committed to fair and accessible employment practices. When requested, Cencora will accommodate people with disabilities during the recruitment, assessment and hiring processes and during employment.

Affiliated Companies: Affiliated Companies: Innomar Strategies