Quality Assurance Analyst III - Shop Floor (Wknd Shift)

THIS ROLE WILL REQUIRE Maryland RELOCATION

This Permanent Full-Time Position offers a fantastic working culture and an exceptionally competitive compensation package.

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Quality Assurance Analyst III - Shop Floor (Wknd Shift)

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Our team at PharmAllies has teamed up with a mid-sized biopharma manufacturing firm to supply them with the personnel needed for critical COVID vaccine manufacturing efforts. This company values diversity and growth opportunities for its staff. So, if you want to make a worldwide health impact, take a look at our available positions, and apply today!

Job Summary

The Analyst III, Shop Floor is responsible for assisting and supporting Quality Assurance activities in support of Phase I, II, III and commercial manufacturing of biotechnology products. This position is suitable for an employee who has a potential for growth and development in all areas of quality support such as supporting internal/external inspections, investigations, and corrective and preventative actions.The incumbent will interact with external CMO clients, senior leadership, direct manager, peers, internal customers, and other cross functional peers across Company to gain alignment on sound quality decisions. This position will support our site site which operates on a 24/7 schedule. This position will support the weekend shift. However, due to the needs of company or departmental needs, those hours are subject to change.

Essential Functions

Reasonable accommodations will be made to enable individuals with disabilities to perform the essential functions.

• Support/execute QA on the Floor program to provide quality oversight of manufacturing operations.
• Work closely with technical, quality, and operational management to address any observations noted during execution.
• Provide sound quality judgement in a fast-paced scenario, and escalate when needed.
• Establish good rapport and work closely with manufacturing personnel to help drive a Quality mindset.
• Support/execute real-time Batch Record review of executed/Master Batch Records on the floor.
• Support/execute revision and creation of Standard Operating Procedures in document management system.
• Support internal customers in manufacturing, QC, Engineering and Facilities, Validation, Supply Chain, Procurement, and QA.
• Support cross functional teams made up of employees at various experience levels and provide input as needed on Quality/compliance issues.
• Support the generation of QA operations metrics.
• Exercise judgment within defined site procedures to determine appropriate action for resolution of technical issues.
• Receive assignments in the form of objectives to help achieve department goals.
• Participate in company sponsored training.
• Support regulatory and client audits.
• Provide Quality input/support to investigations, CAPA’s and changes.
• Support site inspection readiness strategy and activities.
• Support internal audits per audit schedule.

The above statements are intended to describe the nature of work performed by those in this job and are not an exhaustive list of all duties. Nothing in this job description restricts managements right to assign or reassign duties and responsibilities to this job at any time which reflects management’s assignment of essential functions.

Education and Skills

• BS degree or equivalent years of experience in the field.
• Minimum 5 years’ experience supporting GMP manufacturing; conducting facility/lab walkthroughs, supporting a QA on the Floor Program, releasing raw materials in SAP, identifying compliance risk and gaps, providing Quality input/oversight of potential manufacturing/lab deviations and performing batch record review on executed/master batch records
• Preferred experience in biologic drug substance manufacturing.
• Experienced in application of GMP principles, Minimum of 2 years in an FDA or other equivalent regulated industry.
• Strong computer skills with the Microsoft Office product line.
• Moderate understanding of regulations governing document control and records management.
• Ability to effectively communicate (orally and written) with all levels of personnel at multiple company locations.
• Experienced with US, EU and Canadian pharmaceutical regulations, ISO standards.
• Strong communication skills: oral/written and listening.
• Ability to work individually and in a team environment.
• Ability to work under pressure and analyze processes within scheduled timeframes.
• Strong presentation skills, including written and verbal communication skills.
• Experience in SAP and Technical Writing.

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Job Type: Full-time

Pay: From $1.00 per year

Benefits:

• 401(k)
• 401(k) matching
• Dental insurance
• Health insurance
• Paid time off
• Parental leave
• Vision insurance

Schedule:

• 8 hour shift

Supplemental Pay:

• Bonus pay

Application Question(s):

• Will you now, or in the future require our company to commence (sponsor) an immigration case in order to employ you (for example, H-1B or other employment-based immigration case)?
• Will you be able to commute or relocate to MARYLAND for this job?

Education:

• Bachelor's (Required)

Experience:

• Pharmaceutical: 5 years (Required)
• Biopharmaceutical: 5 years (Preferred)

Work Location: One location