Quality Assurance (QA) Manager - Pharma
Company: Job Juncture
Posted on: September 22, 2022
The Quality Assurance Manager, Manufacturing is responsible for
the overall performance of the Manufacturing Quality Assurance team
to maintain GMP Compliance, enforce good documentation
--- Oversees, manages, coordinates, and prioritizes the daily
activities related to Manufacturing QA inspectors such as sampling,
inspection, equipment challenges, batch record review, issuance and
control of printed material, line clearances, and retain
--- Ensures cGMP and FDA compliance by all manufacturing employees
to best practices, standards and quality.
--- Partners with Technical Operations, Engineering, and Validation
departments to identify Quality and Compliance risks and develop /
implement plans to mitigate via a risk management approach.
--- Ensures and enforces departmental compliance of all related
facility SOPs and cGMPs.
--- Oversee release of Manufacturing Controlled Area, passivation
records, conditional releases, cleaning verifications, water
releases and Notice of Rejection records.
--- Responsible for QA hold, Sample request processes as well as
final QA approval manufacturing work orders
--- Ensure training is up to date for all team members to remain
--- Review, Assess, and approve deviation reports, change controls,
product complaints, product specifications, manufacturing /
engineering protocols, SOPs, master batch records and forms.
--- Participates in the recruitment process of interviewing and
--- Conducts performance evaluations of direct reports and assists
direct report supervisors with the performance evaluation
--- Lead continuous improvement program for Quality Assurance
--- Collaborate and interact internally and with customers for Root
Cause Problem Solving events to address investigations and customer
inquiries from a Quality perspective.
--- Prepare monthly and/or quarterly quality metric
--- Support client audits and regulatory inspections for QA.
--- Utilize investigative techniques to determine root causes of
deviations and to determine the proper corrective and preventive
--- Responsible for workforce management activities including, but
not limited to, interviewing, hiring, training, coaching
performance management, discipline, and termination
--- Develop, motivate, and lead direct reports towards achieving
--- Lead Tier 2 Daily meetings and attend Tier 3 daily meetings as
the Quality Assurance lead.
--- Responsible for scheduling. Facilitates transitions between
shifts and seamless handoffs. Communicates key information to
peers, team members and production management.
- Bachelor's degree (BA or BS), preferably in a Chemistry,
Biology, Pharmacy, Engineering, or other related technical or
business administration field.
- Minimum of 5 years of relevant experience in the pharmaceutical
industry for Quality Assurance and Manufacturing
- 5 years or more of management of people, projects, functional
area or a combination is preferred.
- Excellent written and oral communication skills, sound
decision-making based on experience, good supervisory skills
including the ability to delegate effectively, good people-skills
including the ability to coach and teach subordinates.
Keywords: Job Juncture, Brick , Quality Assurance (QA) Manager - Pharma, Executive , Jackson, New Jersey
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