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Senior Quality Assurance Associate
4 months ago
Shift: Rotating night shift (D shift), with five day working during one week (M, Tu, F, Sa, Su) and two days the following week (W, Th), shift hours are 7pm to 7am.
Description:
ONSITE 100% - PQA Sr. Associate (Nights)
QA Sr. Associate will be responsible for Quality On the Floor in support of Manufacturing activities. This position provides the opportunity to work directly with Manufacturing staff during bulk drug substance operations to facilitate batch record and attachment reviews, logbook reviews, area changeover reviews, real-time decision-making regarding quality requirements.
This is a unique opportunity to foster a strong partnership and learning environment between Manufacturing and Quality staff. This position works a rotating night shift (D shift), with five day working during one week (M, Tu, F, Sa, Su) and two days the following week (W, Th), shift hours are 7pm to 7am, with adaptability as required based on the business needs, provides coaching, guidance and direction to Manufacturing, Quality Control and Facilities & Engineering staff in regards to compliance and quality systems.
· How is the shift schedule decided upon each week? Is there a rotation or a set schedule for EW’s?
Schedule is pre-determined for entire year, aligning with MFG schedule. It’s rotating, yes, see above response for days/timing. EW will be following D shift rotation, 7 days across two weeks, 12 hr shift each night.
· What type of qualities/characteristics are you looking for in candidates to work best with your team?
· Team player, and good communicator. Willing to support additional workload by checking with team members, good communication with the team members on a daily basis of what needs to be prioritized and what has been completed, and understanding of when to escalate events to me.
Minimum Education
Master’s degree OR Bachelor’s degree and 2 years of experience (in QA or MFG) OR Associate’s degree and 6 years of experience (in QA or MFG).
Top 3 Must Have Skill Sets:
- Industry experience in BioTech or Pharmaceuticals.
- Quality or Manufacturing experience.
- Academic background in Sciences.
Day to Day Responsibilities:
- Provide Quality oversight to ensure that operations products are manufactured, tested, stored, and distributed according to current Good Manufacturing Practices (cGMP), Good Distribution Practices (GDP) and other applicable regulations.
- Ensure that facilities, equipment, materials, organization, processes, procedures and products follow cGMP practices and other applicable regulations.
- Performs review and approval of cGMP processes, procedures, documents and records.
- Ensure that changes that could potentially impact product quality are assessed according to procedures.
- Review executed batch records, attachments, and area logbooks.
- Ensure that production records and testing results are complete, accurate, and documented according to written procedures and cGMP requirements.
- Alert senior management of quality, compliance, supply and safety risks.
- Complete required assigned training to permit execution of required tasks.
