QC Analyst

NextPharma is a leading European pharmaceutical CDMO focused on attractive technology niches.

Since its foundation in 1989, the Livingston site has evolved into a global player in the development and application of both traditional and novel drug encapsulation technologies that are supported by modern and commercial scale manufacturing facilities.

Our Vision:

Our vision is to be the leading and most trusted, reliable and innovative Europe-based CDMO by upholding the highest industry standards and exceeding customer expectations, while driving strong, sustainable growth for the company.

This role reports to the Quality Control Team Leader and will primarily be responsible for the conducting analytical activities, QC testing and release of materials, packaging components and finished products. The role will be responsible for providing technical expertise at both a theoretical and practical level. The ideal candidate will therefore have a pharmaceutical analysis background and have gained experience within a cGMP, FDA and MHRA regulated environment.Job Purpose:

To support the production of both development and market finished products under GMP conditions in all areas of quality control and calibration

Key responsibilities and accountabilities:

1. Work as part of a team alongside Production and other analytical departments development and stability.

2. Actively involved in performing analytical activities to determine fitness for purpose of starting materials, intermediate and finished products

3. Technically competent in analytical activities (e.g., pharmacopeial wet chemistry, HPLC, GC, Dissolution) for QC testing of raw materials, packaging components and finished products. All activities to be performed under current cGMP, In house SOP’s and/or pharmacopoeia

4. Perform sampling of starting materials, packaging components and finished products

5. Perform cleaning verification analysis to assure suitability of Production equipment for subsequent use

6. Support calibration of key analytical equipment and measuring devices used in or on production equipment

7. Comply with company health and safety procedures.

Person Profile: Quality Control Analyst

Personality:

Results oriented with a positive outlook and clear focus on high quality output: Solid planning and organizational ability; Reliable, tolerant, and dependable: Comfortable dealing with senior managers and customers: Enjoy working in a fast, stimulating environment. Goal-oriented: Able to work under pressure and meet deadlines; Excellent communication/ presentation skills. Able to get on with others and be a team player but equally comfortable working independently.

Personal Situation

Flexible and able to work extended hours when required.

Specific Job Skills:

Required:

· Relevant qualification, HNC/HND/Science Degree or Equivalent

· An understanding of drug development and manufacturing processes

· Demonstrated technical competence of the technical and practical skills involved in analytical activities to prescribed quality standards

· Skilled in analytical techniques e.g., HPLC, Dissolution, Gas Chromatography, and wet chemistry techniques

· Able to communicate well with others, both laboratory and non-laboratory based

· Able to work with minimal supervision.

· Good understanding of quality control, SOP and GMP adherence

Desired:

· Have a broad knowledge with and experience of working within a cGMP/GLP environment.

· Experience of working within a pharmaceutical or biotechnology industry

· Ability to work to key regulatory and compliance requirements

· Experience of quality control within a pharmaceutical environment

· Experience of Chromeleon software

· Experience of data reporting and checking data within a QC environment

· Understand and demonstrate a pragmatic approach to problem solving with GMP constraints.

Computer skills:Must be competent in the use of MS Office, particularly Excel and Word,
e-mail and internet. Previous use of chromatographic acquisition software is desired but not essential.

Literacy and Numeracy:Must be competent in writing reports both for internal use and for customers. Must be competent in the interpretation of analytical data.

Business Presentation Skills: Must be an excellent face-to-face and telephone communicator.

Job Types: Full-time, Permanent

Benefits:

• Casual dress
• Company pension
• Cycle to work scheme
• Free parking
• Life insurance
• On-site parking
• Private medical insurance
• Referral programme
• Sick pay
• Wellness programme

Schedule:

• 8 hour shift
• Monday to Friday

Ability to commute/relocate:

• Livingston: reliably commute or plan to relocate before starting work (required)

Work authorisation:

• United Kingdom (required)

Work Location: In person