Careers

Summary

The HR Generalist/Office Manager position effectively coordinates and supports human resources and general office management activities. This position functions as a general ambassador and communication interface with employees and external partners.

Essential Duties and Responsibilities

• Helps administer benefit programs, including processing enrollments, changes and terminations and supports employees understanding of benefits.
• Processes required documentation through payroll and insurance providers to ensure accurate record keeping and proper deductions as well as review benefit statements.
• Supports recruitment efforts and coordinates interviews, including travel logistics (air and hotel booking).
• Coordinates on-boarding efforts and orientations for new employees, including I-9 verification and background screenings.
• Records all PTO, Vacation and Sick time for employees and ensures accurate records are maintained.
• Updates and maintains organizational charts and contact lists
• Assists with planning and executing company events and outings and coordinating company meetings and or luncheons.
• Supports the performance review process, as needed.
• Drafts employee communications, job descriptions and other HR related documentation.
• Identifies training needs and helps develop curriculum for such training in collaboration with the Director of HR; monitors all training programs to ensure training objectives are met.
• Assists with developing and rolling out Company policies, programs and solutions.
• Supports the culture and goals of the Company.
• Makes photocopies, mails, scans and emails documents and performs other clerical duties for the office staff.
• Maintains confidential and sensitive information involving employees and the Company.
• Assist in travel and accommodation arrangements for the executive staff. 
• Greet and assist all company visitors in a helpful and professional manner.
• Communicate with the building on maintenance issues, community events and company updates.
• Handles office management responsibilities including, maintaining inventory, ordering supplies, receiving deliveries, coordinating improvements and office furniture maintenance.
• Other duties may be assigned.

Supervisory Responsibilities

None.

Competencies

• Agile 
• Strategic Thinker
• Written and Verbal Communication Skills
• Problem Solving
• Interpersonal
• Professionalism

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.

• Possesses the following characteristics: customer service focused, proactive, flexible, approachable, courteous, tactful and diplomatic.
• Demonstrated skill proficiency in Microsoft Office.
• Excellent organizational skills, effective project management skills and commitment to meeting deadlines.
• Possesses oral and written communication skills with an ability to work independently as well as within a group setting and can interface across multiple departments and levels of management.
• Self-motivated, detail oriented, takes the initiative and has the ability to work with general supervision.
• Must be circumspect in handling highly confidential and sensitive information.
• Understands and applies Meitheal values, maintains and demonstrates high ethical standards in conducting Meitheal’ s business.

Education and/or Experience Required

• Associate degree in HR related field required (Bachelor’s preferred) or equivalent HR experience.
• 3-5 years’ experience in human resource and office management.
• Broad knowledge in change management, employment law, employee relations and training and development. 
• Experience in the pharmaceutical industry or healthcare is a plus.

Language Skills

Excellent communication skills.

Computer Skills

Intermediate computer skills (including Microsoft Office).

Physical Demands

While performing the duties of this Job, the employee is regularly required to sit. The employee is frequently required to talk or hear. The employee is occasionally required to stand and walk. The employee must occasionally lift and/or move up to 25 pounds. 

Work Environment

The noise level in the work environment is usually moderate.

AAP/EEO Statement

Equal Opportunity Employer Minorities/Women/Veterans/Disabled.

Summary

The Quality Auditor position is primary responsible for the management of quality, compliance, and auditing activities for the Supplier Audit process of Meitheal’s partners ensuring compliance with applicable U.S. FDA cGMP regulations and industry standards. 

Essential Duties and Responsibilities

• Manages Supplier Quality Audit activities, including:

1. Scheduling and planning supplier audit activity.
2. Ensuring adherence to audit schedule.
3. Writing audit plans and reports.
4. Conducting internal audits of Meitheal’s quality systems and reporting findings to the Vice President of Quality and Meitheal management as necessary.
5. Conducting supplier audits and reporting findings to partners and Meitheal management.
6. Tracking, reporting and managing audit records, including audit findings, within TrackWise Digital system through closure.
7. Evaluating audit finding responses from partners for adequacy, including root cause determination and timeliness. 
8. Managing and overseeing approved vendor list.
9. Collecting, trending and reporting supplier quality metrics.
10. Performing due diligence reviews and audit of potential suppliers.
11. Reviewing product specific documentation (process validation reports, product specifications) to include additional products to an already approved supplier.

• Prepares and publishes yearly partner performance evaluations as part of continued supplier monitoring activities.
• Prepares and publishes annual product quality reviews.
• Supports management during external inspections.
• Assists in generating partner Quality Agreements.
• Remains current in regulatory trends and requirements.
• Provides support to other areas in quality department, including but not limited to, batch record review, change control, product complaints, non-conformance investigations, product launches, and supporting existing Meitheal QMS as necessary.  
• Other duties may be assigned.

Supervisory Responsibilities

None.

Competencies

• Code of Federal Regulations and cGMP’s
• Risk based auditing
• Strong written and oral communications skills
• Planning and Organizing
• Interpersonal
• Team Work
• Problem Solving
• Quality Management
• Judgement
• Dependability
• Ethics

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 Required

• Bachelor’s degree in science or equivalent degree. 5-7 years’ experience in Quality and Manufacturing with a pharmaceutical company or similarly regulated industry.
• Background in aseptic processing and experience working in a cGMP production environment, preferably with injectables.
• Previous auditing experience required, and ASQ and/or other accreditation is highly desirable.
• In depth knowledge of cGMP and GLP.
• Strong interpersonal skills and great attention to detail are necessary.
• Must be a strong team player with good problem solving and good verbal and written communication skills.
• Must be able to handle multiple projects concurrently.
• Willingness to travel both domestically and internationally (up to 25%-50%).

Language Skills

Excellent communication skills.

Computer Skills

Microsoft Word, PowerPoint, Excel, TrackWise Digital preferred but not required.

Physical Demands

While performing the duties of this Job, the employee is regularly required to sit. The employee is frequently required to talk or hear. The employee is occasionally required to stand and walk. The employee must occasionally lift and/or move up to 25 pounds. 

Work Environment

The noise level in the work environment is usually moderate.

AAP/EEO Statement

Equal Opportunity Employer Minorities/Women/Veterans/Disabled.

Summary

The Staff Accountant position supports the Company’s high growth objectives, goals and strategies under the guidance of the Controller. The Staff Accountant position supports the month end close process, performs accounts receivable (including gross to net adjustments) and other projects as needed. 

Essential Duties and Responsibilities

• Assists in month end close process, including revenue, inventory, fixed assets, prepaids and supply chain accounting, reconciliation and analysis.
• Analyzes, processes and resolves chargebacks items to establish appropriate credit within the contractual requirements through extensive research of EDI submissions to resolve discrepancies between wholesaler requests for credit and the Meitheal chargeback system.
• Performs corporate accounts payable and accounts receivable functions. 
• Reviews results on a monthly basis and provides variance analysis.
• Prepares and maintains accounting documentation, including technical accounting research on complex accounting issues and documents the position papers.
• Independently and timely performs non-recurring, one-off projects and other analyses as delegated by the Controller.
• Other duties may be assigned.

Supervisory Responsibilities

None.

Competencies

• Business Acumen
• Positive Attitude
• Business/Financial Acumen
• Ethics and Values
• Motivation
• Critical Thinker
• Team Player
• Strong Analytical Skills
• Technologically Proficient
• Professionalism

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.

• Ability to utilize advanced finance and accounting experience to manage assigned workload.
• Working knowledge of corporate financial statements, including balance sheet, income statement, and related analytics, including cost center review and comparison to budget and forecast.
• Able to quickly establish a personal brand within the organization to drive cross functional collaboration.
• Curious mindset that proactively seeks understanding and feedback.

Language Skills

Excellent communication skills.

Education and/or Experience Required

• Bachelor’s degree in Accounting, Finance or related area is required.
• Minimum of 1-3 years of experience with Pharmaceutical industry experience preferred.  
• Solid understanding of U.S. GAAP and management reporting and analysis.

Computer Skills

Microsoft Word, PowerPoint, Excel.

Physical Demands

While performing the duties of this Job, the employee is regularly required to sit. The employee is occasionally required to stand and walk. The employee must occasionally lift and/or move up to 25 pounds.  

Work Environment

The noise level in the work environment is usually moderate.

AAP/EEO Statement

Equal Opportunity Employer Minorities/Women/Veterans/Disabled.