Working as part of the Almac Sciences Quality Validation Department and Quality Assurance Department you will be responsible for the day-to-day Support of the Almac Sciences Quality Management System in the Souderton Laboratory and Stability Facilities and for assuring its compliance to GMP Requirements.


Essential Functions:

A. Perform day-to-day QVT (Quality Validation Team) duties to support the Almac Sciences Quality Management System including:
Support QVT by maintaining and scheduling the onsite/external maintenance and calibration of instruments
Liaison with equipment engineers/technicians that come onsite
Package and dispatch of instrumentation to offsite vendors for calibration, service or repair
Author, scan, file, and archive equipment maintenance, validation and analytical documentation
Ensure that the validation status of Analytical Equipment, Instrumentation, Facilities and associated Software is maintained in accordance with cGMP and other regulatory standards, at all times.
Assist QVT and QA in the handling of reviewed documents
(80%)

B. Perform day-to-day QA (Quality Assurance) duties to support the Almac Sciences Quality Management System including:
Manage the document control requirements of the Document Control Matrix (DCM) and manage archival of GMP documents
Review and approve documents associated with assigned projects including the final release of data to customers
Review and approve document change requests as required. This will include final approval of the associated documents
Generation of KPI data for Quality Metrics
Represent Almac Sciences, Souderton to customers including customer audits, technical visits and conference calls. This may also include representation at Regulatory Inspections (FDA)
(20%)

Additional Functions:
1. Participate in training to gain understanding of all QVT and QA functions.
2. Assist in controlling workbook distribution and maintain associated logbook.
3. Be responsible for the management of own work schedule and provide regular updates to line manager and team members.

4. Perform other duties as may be deemed appropriate by the QA Manager and that fall within the general responsibilities of the post.

Behavioral Requirements:

Handling multiple responsibilities and job tasks (multi-tasking) as needed.
Demonstrating attention to detail.
Flexibility with work requirements, work environment and fast-paced/changing job needs.
Promote and maintain a high standard of customer care.

Promoting teamwork by:
Collaborating with co-workers.
Attending staff meetings as required.
Meeting individual company goals as established.
Establishing rapport and maintaining positive communication with others, demonstrating respect and support, cooperating and flexibility with change.
Adhering to company and department policies.
Supervisory responsibilities of direct reports: No

Meets Training & Development and HR goals, such as:
Ensuring training has been received before undertaking specific duties and that all training is documented in training records.
Conforming to Company's Policies and Procedures, i.e., Absence/Attendance
Ensuring accurate and timely completion of assigned employee timesheets

General Requirements:
Maintains technical knowledge by attending educational workshops and/or reviewing publications.
Other duties as assigned by Management

Quality:
Adhere to all Standard Operating Procedures (SOPs) and Good Manufacturing Practice (GMP).

Training & Development:
Ensure training has been received before undertaking specific duties and that all training is documented in training records.

Health & Safety:
Understand the company's Health & Safety Policy and follow all associated procedures. Report all accidents or awareness of any unsafe conditions in the workplace to management.

Human Resource Management:
Conform to the company's policies contained in the Employee Handbook

Basic Qualifications & Position Requirements:

Required Education:
Bachelor's Degree in Sciences or related discipline

Preferred Education: n/a

Required Work Experience:
A minimum of one year experience in a Quality role within the pharmaceutical manufacturing industry
A minimum of one year experience working in an analytical laboratory within the pharmaceutical manufacturing industry
A minimum of one year experience reviewing and approving cGMP documents.
A minimum of one year experience managing multiple projects simultaneously

Preferred experience:
Previous experience within a cGMP/pharmaceutical environment
Previous experience generating or reviewing analytical documents
Prior experience generating or reviewing instrument maintenance, qualification, and validation documentation.
Prior experience in conducting internal audits or other quality compliance activities
Understanding change requests

Required Knowledge:
It is essential to have knowledge of a Quality System involving generation or review of analytical documentation and cGMP
Safe laboratory practices

Preferred Knowledge:
Knowledge of the drug development life cycle
Analytical chemistry, drug substance and drug product
Instrument maintenance, qualification, and validation

Skills:
Excellent organizational and time management skills
Excellent verbal and written communication skills are also essential attributes for this position
Excellent attention to detail
Ability to perform multiple project tasks and meet required deadlines
Ability to be detail-oriented with an emphasis on accuracy and delivery of high quality projects


Additional Qualifications: [examples]
*Customer service/client relations
*Communication proficiency
*Attention to detail
*Can work productively independently with minor supervision
*Self-motivated, flexible, dependable and available
*Excellent organizational and time management skills

• Medical, Vision & Dental benefits from the 1^st of the month following start date
• 20 days PTO per year, accrued monthly following start date
• 12 holidays per year
• Company paid Long and Short-term disability along with Life Insurance
• 401k company contribution
• Professional development programs/ continuous learning opportunities