Quality Assurance Manager

Quality Assurance Manager

Department : Quality Specialty

Location : Allentown, PA

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POSITION DESCRIPTION

Role / Position Title - Quality Assurance Manager

Department / Function - Quality

Country - USA

Region / City (within Country) - Allentown, PA

FLSA (Exempt / Non-Exempt) - Exempt

Hours - 8 a.m. to 5 p.m. in office 5 days per week

OVERALL JOB RESPONSIBILITIES

Note : These statements are not intended to be an exhaustive list of all responsibilities and duties.

Handling QMS (Quality Management System) activities which includes :

Handling of Deviations, Investigations, CAPA, Change Controls

Preparing and reviewing SOPs related to Quality Assurance

Reviewing SOPs related to other departments

Ensuring proper documentation control activities are being followed per cGMP requirements

Coordinating with manufacturing sites in regards to QMS activities

Review and maintaining existing Quality System and ensuring compliance to Agency Regulations / cGMP expectations

Handling employee training and ensure training is carried out and completed per current procedures and regulations

Handling of product quality complaints

Handling of FAR, Recalls and their monthly submissions to Agency

Handling of CMO / Vendor activities which includes :

Preparing and reviewing of Quality Agreements with CMO and Vendors

Ensure that Quality Agreements are being followed

Reviewing and approving CMO QMS documents like Deviations, investigations, protocols, change controls etc.

Handling of product quality complaints for CMOs, coordinating with CMOs and Review and approval of CMO product complaints

Ensure that CMO / Vendor audits are carried out per audit schedule

Perform vendor audits of existing and new CMO / CPO / CTL / Vendors. Initiation, Review and Approval of workflows / Request related to SAP Masters

Preparing / Review of audit reports and carry out follow-ups regarding audit report response from CMO / vendor and ensure adequate implementation of proposed CAPAs by CMO / Vendors.

Coordinate with CMO sites for ongoing activities / updates / projects

Handling of Controlled Substance activities, which includes :

Receiving and storage of controlled substance at Glenmark Mahwah location per current Procedures and DEA regulations

Coordinating with Sales and Marketing for fulfillment of customer orders, processing, shipping and documentation per current DEA regulations,

Handling controlled substance periodic inventory counts

Handling destruction of controlled substances per current procedures and DEA regulations

Handling of ARCOS reporting and state reporting

Ensure all the activities related to controlled substances are carried out per current DEA State and Federal regulations.

Responsible towards cross-departmental projects in providing quality / compliance oversight.

Handling regulatory inspections (FDA, DEA, VAWD / NABP, NJDOH, etc.) and follow up reports / response.

Handle / carry out other QA departmental activities / projects as assigned by supervisor

KNOWLEDGE, SKILLS AND ABILITIES

Education

• Bachler-s degree (or equivalent) in Science

Experience

Knowledge and Skills (Functional / Technical)

Well-versed with current FDA and DEA regulations

Proficient with MS Office (Word, Excel, PowerPoint and Outlook)

SAP or any other ERP system

Physical demands and abilities

The incumbent typically works in an office environment and uses a computer, telephone and other office equipment as needed to perform duties.

The noise level in the work environment is typical of that of an office

Incumbent may encounter frequent interruptions throughout the work day.

The employee is regularly required to sit, talk, or hear; frequently required to use repetitive hand motion, handle or feel, and to stand, walk, reach, bend or lift up to 20 pounds

ABOUT GLENMARK

Glenmark is a global leader in the development and commercialization of generic drugs of the highest quality and value. We help to improve peoples- lives every day by helping to reduce their healthcare costs while delivering high-quality medicines.

Established in 2003 as a North American subsidiary of Glenmark Pharmaceuticals, we launched our first generic product in January 2005 and quickly emerged as one of the leading generic organizations in the United States.

Today we have a diverse business. As a global leader in generics, we are leveraging our industry expertise and success to fuel extensive research to expand development in specialty branded products innovative products that are intended to have a major impact on how people live.

BENEFIT HIGHLIGHTS

Paid time off

401k plus company match

Company paid health benefits

Dental

Vision

Onsite access to company gym

Corporate Discount Program

Paid Employee Referral Program

EAP - Employee Assistance Program

Accident Insurance

Critical Illness Insurance

Commuter Accounts

Short-Term Disability

Life and AD & D Insurance

Whole Life Insurance

Pet Insurance and so much more!

This job description is to serve as a guide. It is intended to be flexible and will continue to evolve over time with business needs and demands and may be updated periodically and at the Company-s discretion. Nothing in this position description changes or is intended to change the employment at-will relationship with the Company. Employment at-will means that an employee or the Company may terminate the employment relationship at any time, for any reason or no reason at all, with or without notice.

Glenmark Pharmaceuticals Inc USA is proud to be an equal opportunity workplace and is an affirmative action employer. We are committed to equal employment opportunity regardless of race, color, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, disability, gender identity or Veteran status.

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